Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked report Injury 1
1 2 3 4 2019-01: 0 reports for this device; peer average 3.17/device 2019-02: 0 reports for this device; peer average 2.75/device 2019-03: 0 reports for this device; peer average 3.02/device 2019-04: 0 reports for this device; peer average 3.16/device 2019-05: 0 reports for this device; peer average 2.59/device 2019-06: 0 reports for this device; peer average 2.77/device 2019-07: 0 reports for this device; peer average 2.83/device 2019-08: 0 reports for this device; peer average 3.3/device 2019-09: 0 reports for this device; peer average 2.66/device 2019-10: 0 reports for this device; peer average 2.47/device 2019-11: 0 reports for this device; peer average 2.53/device 2019-12: 0 reports for this device; peer average 2.21/device 2020-01: 0 reports for this device; peer average 2.52/device 2020-02: 0 reports for this device; peer average 2.49/device 2020-03: 0 reports for this device; peer average 2.5/device 2020-04: 0 reports for this device; peer average 2.95/device 2020-05: 0 reports for this device; peer average 2.22/device 2020-06: 0 reports for this device; peer average 3.28/device 2020-07: 0 reports for this device; peer average 3.37/device 2020-08: 0 reports for this device; peer average 3.08/device 2020-09: 0 reports for this device; peer average 3.63/device 2020-10: 0 reports for this device; peer average 2.3/device 2020-11: 0 reports for this device; peer average 2.23/device 2020-12: 0 reports for this device; peer average 2.48/device 2021-01: 0 reports for this device; peer average 2.98/device 2021-02: 0 reports for this device; peer average 2.58/device 2021-03: 0 reports for this device; peer average 2.99/device 2021-04: 0 reports for this device; peer average 2.58/device 2021-05: 0 reports for this device; peer average 2.13/device 2021-06: 0 reports for this device; peer average 2.7/device 2021-07: 0 reports for this device; peer average 3.3/device 2021-08: 0 reports for this device; peer average 2.8/device 2021-09: 0 reports for this device; peer average 2.61/device 2021-10: 0 reports for this device; peer average 2.74/device 2021-11: 0 reports for this device; peer average 2.5/device 2021-12: 0 reports for this device; peer average 2.6/device 2022-01: 0 reports for this device; peer average 2.98/device 2022-02: 0 reports for this device; peer average 1.97/device 2022-03: 0 reports for this device; peer average 1.98/device 2022-04: 0 reports for this device; peer average 2.56/device 2022-05: 0 reports for this device; peer average 2.41/device 2022-06: 0 reports for this device; peer average 2.63/device 2022-07: 0 reports for this device; peer average 2.13/device 2022-08: 0 reports for this device; peer average 2.16/device 2022-09: 0 reports for this device; peer average 2.25/device 2022-10: 0 reports for this device; peer average 1.99/device 2022-11: 0 reports for this device; peer average 2.69/device 2022-12: 0 reports for this device; peer average 2.99/device 2023-01: 0 reports for this device; peer average 2.66/device 2023-02: 0 reports for this device; peer average 2.71/device 2023-03: 0 reports for this device; peer average 3.22/device 2023-04: 0 reports for this device; peer average 2.33/device 2023-05: 0 reports for this device; peer average 2.53/device 2023-06: 0 reports for this device; peer average 3.14/device 2023-07: 0 reports for this device; peer average 2.29/device 2023-08: 0 reports for this device; peer average 3.08/device 2023-09: 0 reports for this device; peer average 2.61/device 2023-10: 0 reports for this device; peer average 2.6/device 2023-11: 0 reports for this device; peer average 2.92/device 2023-12: 0 reports for this device; peer average 2.57/device 2024-01: 0 reports for this device; peer average 1.94/device 2024-02: 0 reports for this device; peer average 2.42/device 2024-03: 0 reports for this device; peer average 2.48/device 2024-04: 0 reports for this device; peer average 2.65/device 2024-05: 0 reports for this device; peer average 2.55/device 2024-06: 0 reports for this device; peer average 3.03/device 2024-07: 0 reports for this device; peer average 2.43/device 2024-08: 0 reports for this device; peer average 2.76/device 2024-09: 0 reports for this device; peer average 2.52/device 2024-10: 0 reports for this device; peer average 2.9/device 2024-11: 0 reports for this device; peer average 3.39/device 2024-12: 0 reports for this device; peer average 2.79/device 2025-01: 0 reports for this device; peer average 2.85/device 2025-02: 0 reports for this device; peer average 3.81/device 2025-03: 0 reports for this device; peer average 3.82/device 2025-04: 0 reports for this device; peer average 2.98/device 2025-05: 1 reports for this device; peer average 3.48/device 2025-06: 0 reports for this device; peer average 3.08/device 2025-07: 0 reports for this device; peer average 2.54/device 2025-08: 0 reports for this device; peer average 2.48/device 2025-09: 0 reports for this device; peer average 2.55/device 2025-10: 0 reports for this device; peer average 2.63/device 2025-11: 0 reports for this device; peer average 3.96/device 2025-12: 0 reports for this device; peer average 2.64/device 2026-01: 0 reports for this device; peer average 3.4/device 2026-02: 0 reports for this device; peer average 2.63/device 2026-03: 0 reports for this device; peer average 2.87/device 2026-04: 0 reports for this device; peer average 3.31/device 2026-05: 0 reports for this device; peer average 2.41/device 2026-06: 0 reports for this device; peer average 3.1/device 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 Monthly adverse-event reports for this device versus the product-code average. Month This device (reports) Product-code average (reports per device) 2019-01 0 3.17 2019-02 0 2.75 2019-03 0 3.02 2019-04 0 3.16 2019-05 0 2.59 2019-06 0 2.77 2019-07 0 2.83 2019-08 0 3.3 2019-09 0 2.66 2019-10 0 2.47 2019-11 0 2.53 2019-12 0 2.21 2020-01 0 2.52 2020-02 0 2.49 2020-03 0 2.5 2020-04 0 2.95 2020-05 0 2.22 2020-06 0 3.28 2020-07 0 3.37 2020-08 0 3.08 2020-09 0 3.63 2020-10 0 2.3 2020-11 0 2.23 2020-12 0 2.48 2021-01 0 2.98 2021-02 0 2.58 2021-03 0 2.99 2021-04 0 2.58 2021-05 0 2.13 2021-06 0 2.7 2021-07 0 3.3 2021-08 0 2.8 2021-09 0 2.61 2021-10 0 2.74 2021-11 0 2.5 2021-12 0 2.6 2022-01 0 2.98 2022-02 0 1.97 2022-03 0 1.98 2022-04 0 2.56 2022-05 0 2.41 2022-06 0 2.63 2022-07 0 2.13 2022-08 0 2.16 2022-09 0 2.25 2022-10 0 1.99 2022-11 0 2.69 2022-12 0 2.99 2023-01 0 2.66 2023-02 0 2.71 2023-03 0 3.22 2023-04 0 2.33 2023-05 0 2.53 2023-06 0 3.14 2023-07 0 2.29 2023-08 0 3.08 2023-09 0 2.61 2023-10 0 2.6 2023-11 0 2.92 2023-12 0 2.57 2024-01 0 1.94 2024-02 0 2.42 2024-03 0 2.48 2024-04 0 2.65 2024-05 0 2.55 2024-06 0 3.03 2024-07 0 2.43 2024-08 0 2.76 2024-09 0 2.52 2024-10 0 2.9 2024-11 0 3.39 2024-12 0 2.79 2025-01 0 2.85 2025-02 0 3.81 2025-03 0 3.82 2025-04 0 2.98 2025-05 1 3.48 2025-06 0 3.08 2025-07 0 2.54 2025-08 0 2.48 2025-09 0 2.55 2025-10 0 2.63 2025-11 0 3.96 2025-12 0 2.64 2026-01 0 3.4 2026-02 0 2.63 2026-03 0 2.87 2026-04 0 3.31 2026-05 0 2.41 2026-06 0 3.1
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Manufacturer compliance record
Date Type Outcome Facility Citations 2024-01-18 NAI No action indicated Medsource International LLC 0 2017-01-06 VAI Voluntary action indicated Medsource International LLC 3
"EXEL SAFETY PSV SET 21G X 3/4"", 12"" TUBE" Exel International "EXEL SAFETY PSV SET 23G X 3/4"", 12"" TUBE" Exel International "EXEL SAFETY PSV SET 25G X 3/4"", 12"" TUBE" Exel International "EXEL SAFETY PSV/M-S, L-A 21GX3/4"", 12"" TUBE" Exel International "EXEL SAFETY PSV/M-S, L-A 23GX3/4""; 12"" TUBE" Exel International "EXEL SAFETY PSV/M-S, L-A 25GX3/4""; 12"" TUBE" Exel International 00886333610471 ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. ABLE CENTRAL VENOUS CATHETER Guangdong Baihe Medical Technology Co., Ltd. ABLE CENTRAL VENOUS CATHETER Guangdong Baihe Medical Technology Co., Ltd. ABLE CENTRAL VENOUS CATHETER Guangdong Baihe Medical Technology Co., Ltd. ABLE CENTRAL VENOUS CATHETER Guangdong Baihe Medical Technology Co., Ltd. ABLE CENTRAL VENOUS CATHETER Guangdong Baihe Medical Technology Co., Ltd. Compare Select up to two to place side-by-side with this device.