BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221239Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10382902212390), received between Feb 1, 2021 and May 5, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2021Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) FUNGAL CONTAMINATION WAS DISCOVERED ON PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING FUNGAL CONTAMINATION ON 221239 PLATES LOT 1042195.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11780749 ↗MalfunctionMar 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11446577 ↗MalfunctionFeb 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) PLATES WERE DISCOVERED TO BE CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11262080 ↗
Other CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL devices
- BD BBL™ Enriched Thioglycollate Medium 221788Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL160 reports
- BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and MacConkey II Agar I Plate™ 221291Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL106 reports
- BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) 221261Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL1 recall51 reports
- BD BBL™ CDC Anaerobe 5% Sheep Blood Agar 221734Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL63 reports
- BD BBL™ Fluid Thioglycollate Medium 221196Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL1 recall4 reports
- BD BBL™ Trypticase™ Soy Broth 221716Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL31 reports
- BD BBL™ Trypticase™ Soy Broth 297354Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL27 reports
- BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) 221283Becton, Dickinson And Company · CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.