BD BBL™ Trypticase™ Soy Broth 221093Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30382902210932), received between Aug 1, 2019 and Oct 24, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 18, 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.

• MalfunctionOct 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT GRAM-NEGATIVE BACILLI WERE OBSERVED IN A GRAM STAIN OF A CSF CULTURE AFTER 5 DAYS INCUBATION AT 35°C. THE END USER SUSPECTED CONTAMINATION AND PERFORMED A GRAM STAIN ON UNUSED SOY BROTH. GRAM-NEGATIVE BACILLI WERE OBSERVED IN AN UNSPECIFIED NUMBER OF TUBES. SUBCULTURE OF THE BROTH RESULTED IN NO GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20530051 ↗
• MalfunctionOct 12, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING CONTAMINATED TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921493 ↗
• MalfunctionAug 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH WAS FOUND CONTAMINATED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS TSB 221093__3129898 CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553715 ↗
• MalfunctionAug 11, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS BIOLOGICAL CONTAMINATION OF 4 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING CONTAMINATION AND EVAPORATION OF PRODUCT 221093 LOT NO. 3096339. ONE LOOKS TO BE FUNGAL, AND THE OTHER CONTAMINATED TUBE LOOKS TO BE BACTERIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515898 ↗
• MalfunctionMar 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH BOTTLES CONTAINED SUSPENDED PARTICLES THAT HAVE SIMILAR APPEARANCE TO FUNGAL INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY NOTICED THAT ALL THE BOTTLES CONTAIN SUSPENDED PARTICLES. IT IS QUITE DISTURBING FOR THEM BECAUSE THE FUNGAL INFECTION CAN PRODUCE A SIMILAR APPEARANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579926 ↗
• MalfunctionJun 18, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING LOT NUMBER ON TUBE LABELS DOESN¿T MATCH LOT NUMBER ON PACKAGING LABELS FOR PRODUCT 221093".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025739 ↗
• MalfunctionMar 27, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ TRYPTICASE¿ SOY BROTH FOREIGN MATTER WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTED THAT THERE WERE SEDIMENTS AT THE BOTTOM OF THE TUBES 221093 LOT 0364881.3 BOXES WERE INSPECTED FROM AN ORDER OF 8 BOXES (100 TUBES EACH). CUSTOMER STATED THAT A MAJORITY OF THE TUBES WERE AFFECTED. THE TECH GRAM-STAINED THE TUBES AND GRAM POSITIVE ROD WAS FOUND. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579719 ↗
• MalfunctionAug 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THE CUSTOMER ALLEGED THAT THE MEDIA WAS DEFECTIVE AND WAS CAUSING NON-SPECIFIC ISSUES WITH CULTURING AND PROCESSING TISSUES. THE CUSTOMER INDICATED THE USE OF THE MEDIA RESULTED IN DISCREPANT RESULTS AND LOSS OF DONOR TISSUE. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED. THREE ATTEMPTS WERE MADE TO FOLLOW-UP FOR ADDITIONAL INFORMATION WITHOUT A RESPONSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851314 ↗