Print-ready dossier — use your browser's print dialog to save as PDF.
BD Hypoint™
Model 300253 · BECTON DICKINSON MEDICAL (S) PTE LTD · DI 00382903002535
FMI — Needle, Hypodermic, Single Lumen · Class II · 21 CFR 880.5570
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (31)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 30 · Injury: 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
2.38
2019-02
1
3.67
2019-03
0
2.17
2019-04
0
2.59
2019-05
0
2.17
2019-06
0
2.21
2019-07
1
2.16
2019-08
1
2.91
2019-09
0
3.04
2019-10
1
3.32
2019-11
0
3.07
2019-12
0
2.29
2020-01
0
2.75
2020-02
1
3.17
2020-03
1
2.82
2020-04
0
3.38
2020-05
0
3.83
2020-06
0
3.54
2020-07
0
3.63
2020-08
0
3.98
2020-09
0
2.95
2020-10
0
3.43
2020-11
0
2.99
2020-12
1
2.78
2021-01
0
3.74
2021-02
0
2.89
2021-03
2
3.04
2021-04
0
3.01
2021-05
0
3.81
2021-06
2
3.37
2021-07
0
2.85
2021-08
2
2.84
2021-09
0
3.65
2021-10
0
3.79
2021-11
0
2.48
2021-12
0
3.09
2022-01
0
3.5
2022-02
0
4.24
2022-03
0
2.76
2022-04
1
3.5
2022-05
0
2.98
2022-06
0
2.58
2022-07
0
3.1
2022-08
1
4.17
2022-09
0
4.83
2022-10
1
6
2022-11
1
7.4
2022-12
1
5.84
2023-01
0
3.6
2023-02
0
3.35
2023-03
0
4.19
2023-04
0
3.63
2023-05
1
4.06
2023-06
1
3.87
2023-07
0
3.7
2023-08
1
5.07
2023-09
0
4.38
2023-10
0
4.27
2023-11
0
4.31
2023-12
0
3.4
2024-01
0
3.74
2024-02
0
3.02
2024-03
1
3.69
2024-04
6
2.71
2024-05
0
2.81
2024-06
0
2.45
2024-07
0
2.38
2024-08
1
2.77
2024-09
0
2.71
2024-10
0
4.42
2024-11
1
3.25
2024-12
0
3.24
2025-01
0
2.72
2025-02
0
2.45
2025-03
1
1.98
2025-04
0
2.12
2025-05
0
3.03
2025-06
0
2.33
2025-07
0
1.62
2025-08
0
1.9
2025-09
0
1.98
2025-10
0
2
2025-11
0
2.78
2025-12
0
2.08
2026-01
0
2.14
2026-02
0
1.59
2026-03
0
1.94
2026-04
0
2.06
2026-05
0
1.97
2026-06
0
2.1
This device (reports/month)Average device in FMI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K070440 — cited as predicate by K092831, K110697, K112057, K130230, K132552, K253047
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — BECTON DICKINSON MEDICAL (S) PTE LTD