BD BBL™ Thioglycollate Medium without Indicator - 135C 221200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30382902212004), received between Sep 27, 2021 and Jun 27, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR WAS CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATED THIOS CONTAMINATION NOTICED AT A LATER TIME - ON (B)(6) 2023. STORED AT 2-8C WITH NO RECENT TEMP EXCURSIONS. CONTAMINATION NOTICED BEFORE INOCULATION. MEDIA NOT GRAM STAINED, IDENTIFIED, OR SUBCULTURED AFFECTED PRODUCT NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209822 ↗
• MalfunctionMay 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT CONTAMINATION OF CAT#221200 BROTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002565 ↗
• MalfunctionMay 17, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR CONTAINED NON VIABLE GNB THAT ARE EVIDENT ON GRAM STAIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THAT ITEM 221200, LOT# 3060894 CONTAINS NON VIABLE GNB THAT ARE EVIDENT ON GRAM STAIN AND COULD BE REPORTED ON PATIENT SPECIMENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948970 ↗
• MalfunctionMay 16, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR THERE WERE 3 OCCURRENCES OF POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA THESE WERE SHOWING UP ON SOME GRAM STAINS WE WERE DOING ON TISSUE CULTURES THAT WE USED THIO BROTH TO GRIND UP FOR CULTURE. BECAUSE WE SAW THE GRAM-NEGATIVE RODS IN THE GRAM STAINS ON A FEW TISSUE CULTURES, BUT NOT GROWING ON ANY MEDIA, WE QUESTIONED IF THERE WAS SOME KIND OF CONTAMINANT. WE TESTED THE TISSUE GRINDERS, THIO BROTH AND SLIDES. THE THIO BROTH WAS WHAT HAD THE CONTAMINANT OF THE NON-VIABLE GRAM-NEGATIVE RODS IN THEM. ONE WAS REPORTED ON A PRELIMINARY GRAM STAIN REPORT. AND IT WAS PROMPTLY CORRECTED/CALLED AFTERWARDS. THE OTHERS WERE NOT REPORTED IN THE RESPECTIVE PATIENTS EMR. THEY WERE ABOUT 6 CULTURES BELONGING TO 3 DIFFERENT PATIENTS. LOT #2241644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942646 ↗
• MalfunctionMay 16, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR THERE WERE 3 OCCURRENCES OF POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA. THESE WERE SHOWING UP ON SOME GRAM STAINS WE WERE DOING ON TISSUE CULTURES THAT WE USED THIO BROTH TO GRIND UP FOR CULTURE. BECAUSE WE SAW THE GRAM-NEGATIVE RODS IN THE GRAM STAINS ON A FEW TISSUE CULTURES, BUT NOT GROWING ON ANY MEDIA, WE QUESTIONED IF THERE WAS SOME KIND OF CONTAMINANT. WE TESTED THE TISSUE GRINDERS, THIO BROTH AND SLIDES. THE THIO BROTH WAS WHAT HAD THE CONTAMINANT OF THE NON-VIABLE GRAM-NEGATIVE RODS IN THEM. ONE WAS REPORTED ON A PRELIMINARY GRAM STAIN REPORT. AND IT WAS PROMPTLY CORRECTED/CALLED AFTERWARDS. THE OTHERS WERE NOT REPORTED IN THE RESPECTIVE PATIENTS EMR. THEY WERE ABOUT 6 CULTURES BELONGING TO 3 DIFFERENT PATIENTS. LOT #2241644

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939405 ↗
• MalfunctionFeb 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR THERE WERE 3 OCCURRENCES OF POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA. THESE WERE SHOWING UP ON SOME GRAM STAINS WE WERE DOING ON TISSUE CULTURES THAT WE USED THIO BROTH TO GRIND UP FOR CULTURE. BECAUSE WE SAW THE GRAM-NEGATIVE RODS IN THE GRAM STAINS ON A FEW TISSUE CULTURES, BUT NOT GROWING ON ANY MEDIA, WE QUESTIONED IF THERE WAS SOME KIND OF CONTAMINANT. WE TESTED THE TISSUE GRINDERS, THIO BROTH AND SLIDES. THE THIO BROTH WAS WHAT HAD THE CONTAMINANT OF THE NON-VIABLE GRAM-NEGATIVE RODS IN THEM. ONE WAS REPORTED ON A PRELIMINARY GRAM STAIN REPORT. AND IT WAS PROMPTLY CORRECTED/CALLED AFTERWARDS. THE OTHERS WERE NOT REPORTED IN THE RESPECTIVE PATIENTS EMR. THEY WERE ABOUT 6 CULTURES BELONGING TO 3 DIFFERENT PATIENTS. LOT #2241644.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318576 ↗
• MalfunctionMay 5, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT HAS BEEN REPORTED THAT THE BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS CONTAMINATION FOR CAT 221200 LOT 1209940.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292140 ↗
• MalfunctionSep 27, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER HAS 221200 TUBES, LOT 1112942 WITH CONTAMINATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537700 ↗