2026 data FDA MAUDE openFDA FDA Class I

Culture Media, Enriched

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 §866.2330 (Microbiology panel).

FDA MAUDE casebook

openFDA event book Culture Media, Enriched LIGHT-BOOK · MAUDE

#397 of 1000 · 3,141 reports · 2021–2026

  • BOOK 3,141 reports
  • RANK #397 of 1000
  • DEATH 0 death-typed
  • INJ 5 injury-typed
  • MALF 3,136 malfunction
  • SPAN 2021–2026
  • PEAK 2025: 2,713
  • PHOTO Dressing, Wound, Drug

Nearest event-volume peer: Dressing, Wound, Drug (3 report gap)

Culture Media, Enriched sits #397 of 1000 among tracked device types with 3,141 MAUDE reports spanning 2021–2026. 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, Enriched carries 99.8% MALFUNCTION-coded reports, 35.0pp 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 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
  • MALF 99.8% corpus 64.8% · above corpus mean (+35.0 pp)

Lead product-problem code Contamination is 81% of coded problems · Lead manufacturer BECTON DICKINSON GMBH accounts for 83% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Culture Media, Enriched in the event-volume neighbourhood

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

reports

What this shows Culture Media, Enriched carries 3,141 MAUDE reports, ranked #397 of 1000.

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

Event Types

Malfunction 3,136 (99.8%)
Injury 5 (0.2%)

Patient Outcomes

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

3,127 (99.8%)
Life Threatening 5 (0.2%)
Disability 1 (0.0%)
Hospitalization 1 (0.0%)

Top Product Problems

Contamination 2,547
Incorrect, Inadequate or Imprecise Result or Readings 564
Contamination of Device Ingredient or Reagent 14
Device Markings/Labelling Problem 9
Chemical Problem 5
Device Ingredient or Reagent Problem 5
False Positive Result 2
Device Contamination with Chemical or Other Material 1

Yearly Trend

21
2021: 50
22
2022: 41
23
2023: 23
24
2024: 11
25
2025: 2,713
26
2026: 303

Reports rose to 2,713 in 2025, up from an average of 17 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Culture Media, Enriched

Event Locations

3,129 (99.6%)
I 12 (0.4%)

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

Nationwide devices with a comparable report-volume footprint

Culture Media, Enriched 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 (3,141 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Culture Media, Enriched 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, Enriched; 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.