BD BBL™ Trypticase™ Soy Broth 221815Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382902218150), received between Jul 3, 2019 and Jun 7, 2022 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE GETTING INCONSISTENT GROWTH, COLOR AND PH WHEN ADDING AGAR TO THEIR 221815 PREPARED TUBES TO MAKE TSA PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628477 ↗
• MalfunctionJul 6, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING 100 BD BBL¿ TRYPTICASE¿ SOY BROTH BACTERIAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125493 ↗
• MalfunctionJun 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 5 BD BBL¿ TRYPTICASE¿ SOY BROTH NON-VIABLE CONTAMINATION 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 PROBLEM: CUSTOMER REPORTS GRAM VARIABLE RODS IN FLUID. CUSTOMER INSERTS SWABS INTO BROTH AND VORTEXES OUT FOR GROWTH. THERE CAN BE SEEN A LIGHT HAZINESS THAT HAS SETTLED OUT AT BOTTOM OF TUBE CUSTOMER BELIEVES TO BE NON-VIABLE ORGANISMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028745 ↗
• MalfunctionJun 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 40 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION 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: "IT WAS REPORTED THAT THE CUSTOMER REPORTED THE 2ML TSB TUBES THEY RECEIVED FROM LOT 1070138 ARE CONTAMINATED WITH GRAM-POSITIVE RODS. PROBLEM: REPORTED THEY RECEIVED 40 BOXES OF 2ML TSB TUBES FROM LOT 1070138 EXP. 2022/09/03 (ITEM 221815). ALL THE TUBES ARE CONTAMINATED WITH GRAM POSITIVE RODS. THEY CANNOT USE THE PRODUCT AND ARE REQUESTING REPLACEMENT PRODUCT AS SOON AS POSSIBLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952244 ↗
• MalfunctionJun 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION 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: "IT WAS REPORTED THAT CONTAMINATED WITH GRAM-POSITIVE BACILLI. PROBLEM: REPORTED THE 2ML TSB TUBES THEY RECEIVED FROM LOT 1070138 ARE CONTAMINATED WITH GRAM-POSITIVE BACILLI. THEY RECEIVE 2 SP (200 TUBES) FROM LOT 1070138, EXP. 2022/09/03 AND SHE WOULD LIKE TO RECEIVE REPLACEMENT FROM ANOTHER LOT NUMBER. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952124 ↗
• InjuryJul 3, 2019Microbial Contamination of Device

  THIS SUPPLEMENTAL MDR IS TO REPRESENT THE PATIENT IN THE INTENSIVE CARE UNIT FOR WHOM SPECIFIC MEDICAL INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE CUSTOMER SUSPECTED A CONTAMINATION OF TWO BOXES OF BD BBL¿ TRYPTICASE¿ SOY BROTH AFTER 4 PATIENTS WERE TESTED POSITIVE FOR GEOBACILLUS SP. THE CUSTOMER INDICATED GRAM NEGATIVE RODS WERE ALSO PRESENT IN UNUSED MEDIA. PATIENT SAMPLES DID NOT EXHIBIT SIGNS OF BACTERIAL GROWTH IN CULTURE MEDIA. THE PHYSICIAN INITIALLY BASED TREATMENT ON THE GRAM STAIN AND REQUESTED MOLECULAR 16S TESTING TO IDENTIFY THE ORGANISM WHICH RETURNED BACILLUS SP. IT WAS INDICATED THAT PATIENTS WERE TREATED FOR BACILLUS SP. THERE WERE 9 PATIENTS THAT WERE AFFECTED BY THIS CONTAMINATION. ONE PATIENT WAS REPORTED TO HAVE BEEN IN THE PEDIATRIC INTENSIVE CARE UNIT FOR TWO WEEK AS A CONSEQUENCE OF THE RESULTS.

  Patient problems: Bacterial Infection

  MAUDE report 8760580 ↗
• InjuryJul 3, 2019Microbial Contamination of Device

  THIS SUPPLEMENTAL MDR IS TO REPRESENT THE EIGHT PATIENTS WHOSE MEDICAL INFORMATION IS UNKNOWN: IT WAS REPORTED THAT THE CUSTOMER SUSPECTED A CONTAMINATION OF TWO BOXES OF BD BBL¿ TRYPTICASE¿ SOY BROTH AFTER 4 PATIENTS WERE TESTED POSITIVE FOR GEOBACILLUS SP. THE CUSTOMER INDICATED GRAM NEGATIVE RODS WERE ALSO PRESENT IN UNUSED MEDIA. PATIENT SAMPLES DID NOT EXHIBIT SIGNS OF BACTERIAL GROWTH IN CULTURE MEDIA. THE PHYSICIAN INITIALLY BASED TREATMENT ON THE GRAM STAIN AND REQUESTED MOLECULAR 16S TESTING TO IDENTIFY THE ORGANISM WHICH RETURNED BACILLUS SP. IT WAS INDICATED THAT PATIENTS WERE TREATED FOR BACILLUS SP. THERE WERE 9 PATIENTS THAT WERE AFFECTED BY THIS CONTAMINATION. ONE PATIENT WAS REPORTED TO HAVE BEEN IN THE PEDIATRIC INTENSIVE CARE UNIT FOR TWO WEEK AS A CONSEQUENCE OF THE RESULTS. DUE DILIGENCE ATTEMPTS WERE MADE TO UNDERSTAND THE OTHER 8 PATIENTS¿ IMPACT, HOW THEY WERE TREATED, AND THEIR CURRENT CONDITION BUT NO INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Unspecified Infection

  MAUDE report 8760214 ↗