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2026 data FDA MAUDE openFDA FDA Class II

Container, Sharps

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5570 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Container, Sharps LIGHT-BOOK · MAUDE

#671 of 1000 · 979 reports · 1993–2026

  • BOOK 979 reports
  • RANK #671 of 1000
  • DEATH 2 death-typed
  • INJ 147 injury-typed
  • MALF 586 malfunction
  • SPAN 1993–2026
  • PEAK 2021: 85
  • PHOTO Single-Use Reprocesse…

Nearest event-volume peer: Single-Use Reprocessed Ultrasonic Surgical Instruments (1 report gap)

Container, Sharps sits #671 of 1000 among tracked device types with 979 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Container, Sharps carries 15.0% INJURY-coded reports, 15.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 15.0% corpus 30.3% · below corpus mean (-15.3 pp)
  • MALF 59.9% corpus 64.8% · below corpus mean (-5.0 pp)

Lead product-problem code Material Puncture/Hole is 23% of coded problems · Lead manufacturer BECTON DICKINSON accounts for 53% of manufacturer-tagged reports · Top event location I is 30% of location-tagged rows .

Container, Sharps in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Container, Sharps carries 979 MAUDE reports, ranked #671 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 586 (59.9%)
Other 216 (22.1%)
Injury 147 (15.0%)
28 (2.9%)
Death 2 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

528 (53.0%)
Other 365 (36.6%)
Required Intervention 67 (6.7%)
Life Threatening 10 (1.0%)
R 9 (0.9%)
Hospitalization 7 (0.7%)
O 4 (0.4%)
Death 4 (0.4%)
L 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Material Puncture/Hole 202
Break 82
Needle, unsheathed 64
Unknown (for use when the device problem is not known) 49
Component Missing 47
Crack 44
Use of Device Problem 43
Difficult to Open or Close 39
Other (for use when an appropriate device code cannot be identified) 37
Defective Component 33
Device Issue 29
Material Protrusion/Extrusion 28
Detachment Of Device Component 27
Tears, rips, holes in device, device material 27
Device Misassembled During Manufacturing /Shipping 23
Improper or Incorrect Procedure or Method 22
Device Damaged Prior to Use 20
Fail-Safe Design Failure 20
Design/structure problem 17
Malfunction 16

Yearly Trend

93
1993: 1
94
1994: 11
95
1995: 13
96
1996: 52
97
1997: 43
98
1998: 56
99
1999: 49
00
2000: 56
01
2001: 45
02
2002: 36
03
2003: 19
04
2004: 16
05
2005: 13
06
2006: 15
07
2007: 5
08
2008: 21
09
2009: 9
10
2010: 9
11
2011: 16
12
2012: 16
13
2013: 20
14
2014: 13
15
2015: 13
16
2016: 27
17
2017: 39
18
2018: 63
19
2019: 56
20
2020: 62
21
2021: 85
22
2022: 38
23
2023: 34
24
2024: 14
25
2025: 5
26
2026: 9

Reports fell to 5 in 2025, down from an average of 24 in the two years before.

Related Entities for Container, Sharps

Top Manufacturers

BECTON DICKINSON 209
COVIDIEN 183

Event Locations

I 297 (30.3%)
295 (30.1%)
HOSPITAL 221 (22.6%)
OTHER 46 (4.7%)
INVALID DATA 32 (3.3%)
OUTPATIENT TREATMENT FACILITY 22 (2.2%)
NURSING HOME 15 (1.5%)
UNKNOWN 14 (1.4%)
NO INFORMATION 13 (1.3%)
HOME 9 (0.9%)
AMBULATORY SURGICAL FACILITY 8 (0.8%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.5%)
CLINIC - WALK IN, OTHER 2 (0.2%)

Compare BECTON DICKINSON vs COVIDIEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Container, Sharps: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (979 here).

Single-Use Reprocessed Ultrasonic Surgical… 980 Bronchoscope Accessory 977 Hepatitis A Test 982 Digital Breast Tomosynthesis 975

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Container, Sharps are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Container, Sharps; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.