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2026 data FDA MAUDE openFDA FDA Class II

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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 §866.1700 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book Culture Media LIGHT-BOOK · MAUDE

#751 of 1000 · 762 reports · 1998–2026

  • BOOK 762 reports
  • RANK #751 of 1000
  • DEATH 1 death-typed
  • INJ 9 injury-typed
  • MALF 752 malfunction
  • SPAN 1998–2026
  • PEAK 2025: 519
  • PHOTO Table

Nearest event-volume peer: Table, Radiographic, Tilting (0 report gap)

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar sits #751 of 1000 among tracked device types with 762 MAUDE reports spanning 1998–2026. 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

Culture Media carries 98.7% MALFUNCTION-coded reports, 33.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.2% corpus 30.3% · below corpus mean (-29.1 pp)
  • MALF 98.7% corpus 64.8% · above corpus mean (+33.9 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 69% of coded problems · Lead manufacturer BECTON DICKINSON GMBH accounts for 63% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .

Culture Media in the event-volume neighbourhood

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

reports

What this shows Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar carries 762 MAUDE reports, ranked #751 of 1000.

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

Event Types

Malfunction 752 (98.7%)
Injury 9 (1.2%)
Death 1 (0.1%)

Patient Outcomes

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

740 (97.2%)
Other 13 (1.7%)
Required Intervention 7 (0.9%)
Death 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 539
False Positive Result 129
Incorrect Or Inadequate Test Results 39
False Negative Result 18
Break 11
Nonstandard Device 10
Defective Device 5
Contamination 4
Device Markings/Labelling Problem 4
Contamination of Device Ingredient or Reagent 3
High Test Results 3
Component Missing 2
Device Ingredient or Reagent Problem 2
False Device Output 2
False Reading From Device Non-Compliance 2
Spillage, accidental 2
Adverse Event Without Identified Device or Use Problem 1
Crack 1
Device Contamination with Chemical or Other Material 1
Fitting Problem 1

Yearly Trend

98
1998: 10
99
1999: 2
05
2005: 16
06
2006: 9
08
2008: 1
10
2010: 1
11
2011: 1
13
2013: 1
15
2015: 32
16
2016: 17
17
2017: 43
18
2018: 14
19
2019: 9
20
2020: 7
21
2021: 27
22
2022: 8
23
2023: 12
24
2024: 4
25
2025: 519
26
2026: 29

Reports rose to 519 in 2025, up from an average of 8 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Top Manufacturers

BECTON DICKINSON GMBH 370
BECTON DICKINSON & CO. (SPARKS) 127
BECTON, DICKINSON & CO. (SPARKS) 90

Event Locations

618 (81.1%)
I 128 (16.8%)
NOT APPLICABLE 12 (1.6%)
HOSPITAL 4 (0.5%)

Compare BECTON DICKINSON GMBH vs BECTON DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Culture Media: 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 (762 here).

Table, Radiographic, Tilting 762 Enzyme Linked Immunoabsorbent Assay, Rubella 761 Needle, Fistula 761 Gas Control Unit, Cardiopulmonary Bypass 767

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Culture Media 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 Culture Media; 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.