"SOL-M Blunt Fill Needle 18G*1 1/2""" · recalls, adverse events, clearances

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.

16 linked reportsMalfunction 15Injury 1

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	2
2019-02	0	2.6
2019-03	0	2.5
2019-04	0	5.6
2019-05	0	2.75
2019-06	0	3.5
2019-07	0	3
2019-08	0	5.67
2019-09	0	2.5
2019-10	0	5
2019-11	0	4.4
2019-12	0	3.2
2020-01	0	5
2020-02	0	4
2020-03	0	4.75
2020-04	0	2
2020-05	0	2.25
2020-06	0	1
2020-07	0	1.33
2020-08	0	1.67
2020-09	0	1.67
2020-10	0	1.8
2020-11	0	1.67
2020-12	0	1.5
2021-01	0	1.5
2021-02	0	2.8
2021-03	0	1.83
2021-04	0	1.67
2021-05	0	2.5
2021-06	0	4
2021-07	0	1.4
2021-08	0	2.5
2021-09	0	1.67
2021-10	0	1.8
2021-11	0	2
2021-12	0	1.6
2022-01	0	2.25
2022-02	0	1.67
2022-03	0	4
2022-04	0	2.25
2022-05	0	1
2022-06	0	1.67
2022-07	0	1.33
2022-08	0	4
2022-09	0	3
2022-10	0	2
2022-11	0	1.5
2022-12	0	2.67
2023-01	0	4
2023-02	0	3.33
2023-03	1	2.17
2023-04	0	2.8
2023-05	0	2
2023-06	0	1
2023-07	0	3.33
2023-08	0	2.2
2023-09	0	1.6
2023-10	0	2.6
2023-11	0	1.83
2023-12	0	2.75
2024-01	0	2.25
2024-02	0	3
2024-03	0	2.33
2024-04	0	2.29
2024-05	0	3.33
2024-06	0	3.33
2024-07	0	3.75
2024-08	0	1.8
2024-09	0	2.6
2024-10	0	4.5
2024-11	0	3.5
2024-12	0	6.6
2025-01	0	5.5
2025-02	0	10.5
2025-03	0	4.4
2025-04	0	7.33
2025-05	10	6.5
2025-06	0	9.2
2025-07	1	4.5
2025-08	2	2.67
2025-09	0	2.5
2025-10	0	2
2025-11	0	3
2025-12	0	4.25
2026-01	1	1.67
2026-02	0	2.2
2026-03	1	2
2026-04	0	7
2026-05	0	2
2026-06	0	8.43

This device (reports/month)Average device in GAA (reports/device/month)

Failure-mode summaryAI-generated

16 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-03-18	3014312726-2026-00021	Malfunction	Available	model number
2026-01-27	3014312726-2026-00008	Malfunction	Available	model number
2025-08-01	3014312726-2025-00185	Malfunction	Available	model number
2025-08-01	3014312726-2025-00184	Malfunction	Available	model number
2025-07-23	3014312726-2025-00172	Malfunction	Available	model number
2025-05-16	3014312726-2024-00377	Malfunction	Available	model number
2025-05-16	3014312726-2024-00324	Malfunction	Available	model number
2025-05-16	3014312726-2025-00015	Malfunction	Available	model number
2025-05-16	3014312726-2024-00276	Malfunction	Available	model number
2025-05-16	3014312726-2024-00281	Malfunction	Available	model number
2025-05-16	3014312726-2024-00284	Malfunction	Available	model number
2025-05-16	3014312726-2025-00001	Malfunction	Available	model number
2025-05-16	3014312726-2025-00026	Malfunction	Available	model number
2025-05-16	3014312726-2024-00378	Malfunction	Available	model number
2025-05-16	3014312726-2024-00290	Malfunction	Available	model number

Showing 1–15 of 16

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-05-08	VAI	Voluntary action indicated	Sol-Millennium Medical Inc.	4
2024-03-18	WL	Warning Letter	Sol-Millennium Medical Inc.	—
2023-12-20	VAI	Voluntary action indicated	Sol-Millennium Medical Inc.	4

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