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2026 data FDA MAUDE openFDA FDA Class I

Container, Specimen, Sterile

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §864.3250 (Pathology panel).

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FDA MAUDE casebook

openFDA event book Container, Specimen, Sterile LIGHT-BOOK · MAUDE

#867 of 1000 · 539 reports · 1992–2026

  • BOOK 539 reports
  • RANK #867 of 1000
  • DEATH 0 death-typed
  • INJ 17 injury-typed
  • MALF 516 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 85
  • PHOTO Bag

Nearest event-volume peer: Bag, Urinary, Ileostomy (0 report gap)

Container, Specimen, Sterile sits #867 of 1000 among tracked device types with 539 MAUDE reports spanning 1992–2026. 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 →

Malfunction reports run above the device-type norm

Container, Specimen, Sterile carries 95.7% MALFUNCTION-coded reports, 30.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
  • MALF 95.7% corpus 64.8% · above corpus mean (+30.9 pp)

Lead product-problem code Leak/Splash is 21% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (BROKEN BOW) accounts for 26% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Container, Specimen, Sterile in the event-volume neighbourhood

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

reports

What this shows Container, Specimen, Sterile carries 539 MAUDE reports, ranked #867 of 1000.

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

Event Types

Malfunction 516 (95.7%)
Injury 17 (3.2%)
4 (0.7%)
Other 2 (0.4%)

Patient Outcomes

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

316 (60.0%)
Other 187 (35.5%)
Required Intervention 9 (1.7%)
R 5 (0.9%)
L 3 (0.6%)
O 3 (0.6%)
Life Threatening 3 (0.6%)
Hospitalization 1 (0.2%)

Top Product Problems

Leak/Splash 100
Device Contamination with Chemical or Other Material 85
Short Fill 69
Incorrect, Inadequate or Imprecise Result or Readings 55
Device Markings/Labelling Problem 26
Fluid/Blood Leak 19
Break 13
Material Rupture 12
False Positive Result 11
Difficult to Remove 10
Material Separation 10
Crack 8
Incorrect Or Inadequate Test Results 8
Overfill 8
Volume Accuracy Problem 8
Contamination 7
Separation Problem 7
Unsealed Device Packaging 7
Component Missing 6
Improper or Incorrect Procedure or Method 6

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 2
97
1997: 3
99
1999: 1
01
2001: 1
04
2004: 1
05
2005: 1
06
2006: 3
07
2007: 1
08
2008: 1
09
2009: 2
10
2010: 2
12
2012: 1
13
2013: 8
14
2014: 26
15
2015: 12
16
2016: 2
17
2017: 17
18
2018: 45
19
2019: 81
20
2020: 40
21
2021: 22
22
2022: 20
23
2023: 43
24
2024: 39
25
2025: 75
26
2026: 85

Reports rose to 75 in 2025, up from an average of 41 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Container, Specimen, Sterile

Top Manufacturers

BECTON, DICKINSON & CO. (BROKEN BOW) 104
BECTON, DICKINSON & CO., (BD) 93
BECTON, DICKINSON AND COMPANY (BD) 68
BECTON DICKINSON & CO (FRANKLIN LAKES) 53
BECTON, DICKINSON & CO. 39
BECTON DICKINSON 25
Becton Dickinson & CO (Franklin Lakes) 21

Event Locations

283 (52.5%)
I 179 (33.2%)
HOSPITAL 59 (10.9%)
NO INFORMATION 10 (1.9%)
OTHER 4 (0.7%)
HOME 1 (0.2%)
INVALID DATA 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare BECTON, DICKINSON & CO. (BROKEN BOW) vs BECTON, DICKINSON & CO., (BD) →

Nationwide devices with a comparable report-volume footprint

Container, Specimen, Sterile carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (539 here).

Bag, Urinary, Ileostomy 539 Insufflator 540 Accessories, Pump, Infusion 537 Insufflator, Hysteroscopic 541

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Container, Specimen, Sterile 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, Specimen, Sterile; 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.