BD BBL™ Trypticase™ Soy Broth 221716Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 30382902217160), received between Oct 29, 2020 and Sep 2, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Contamination” (14 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A TUBE HAD BIOLOGICAL CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22934343 ↗
• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A TUBE HAD BIOLOGICAL CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933631 ↗
• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A TUBE HAD BIOLOGICAL CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933605 ↗
• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A TUBE HAD BIOLOGICAL CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933494 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905305 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904963 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904949 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904947 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904946 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904945 ↗
• MalfunctionAug 27, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, A PLATE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902447 ↗
• MalfunctionNov 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF 5 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS REPORT ABOUT TRYPTICASE SOY BROTH CONTAMINATION. THERE IS A DISCREPANCY IN THE CULTURE RESULTS WHEN CULTURING THE CATHETER TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150723 ↗
• MalfunctionSep 11, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING WAS RPEORTED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, RECENTLY, IN SMEAR TESTS USING THE BROTH, A SMALL AMOUNT OF G+R OR G-R ARE INDISTINCTLY OBSERVED. TODAY, A GRAM STAINING WAS PERFORMED WITH CENTRIFUGAL SEDIMENTATION FROM SEVERAL UNUSED TUBES, AND G-R WAS OBSERVED. THE BACTERIA WAS FOUND IN THE LOWER PART OF THE TUBES. NO BACTERIA WAS FOUND IN THE UPPER PART. THE CUSTOMER SUSPECTS ENVIRONMENTAL BACTERIA. OCCURRED WITH 5 PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725555 ↗
• MalfunctionAug 15, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TOTAL QUANTITY OF PRODUCT SHOWING DEFECT: 3 CASES. CUSTOMER REPORTING CONTAMINATED MEDIA FOR PRODUCT 221716 LOT NO. 3025455

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552947 ↗
• MalfunctionJul 31, 2023Contamination; Contamination

  IT WAS REPORTED THAT EIGHT BD BBL¿ TRYPTICASE¿ SOY BROTH BACTERIA WAS FOUND IN LOWER PART OF TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, RECENTLY, IN SMEAR TESTS USING THE BROTH, A SMALL AMOUNT OF G+R OR G-R ARE INDISTINCTLY OBSERVED. TODAY, A GRAM STAINING WAS PERFORMED WITH CENTRIFUGAL SEDIMENTATION FROM SEVERAL UNUSED TUBES, AND G-R WAS OBSERVED. THE BACTERIA WAS FOUND IN THE LOWER PART OF THE TUBES. NO BACTERIA WAS FOUND IN THE UPPER PART. THE CUSTOMER SUSPECTS ENVIRONMENTAL BACTERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425144 ↗
• MalfunctionMar 1, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH BACTERIA WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE BEGINNING THE CUSTOMER REPORTED G- BACILLUS AS A PRELIMINARY RESULT AND ANTIBIOTICS WERE GIVEN TO THE PATIENT. AS ALL SAMPLES SEEMS TO CONTAIN G- BACILLUS, THE CUSTOMER STOPPED REPORTING THE PRELIMINARY RESULT TO THE DOCTORS. ADDITIONAL INFO PROVIDED ON PATIENT IMPACT: NO ANTIBIOTICS WERE GIVEN TO PATIENTS 1) HOW MANY PATIENT SAMPLES WERE REPORTED AS A PRELIMINARY RESULT AND GIVEN ANTIBIOTICS? 0 2) PLEASE FOLLOW UP FOR PATIENT IMPACT: - WAS THERE ANY ADVERSE EVENTS AFTER STARTING THE ANTIBIOTIC? IF SO - PLEASE DESCRIBE FOR EACH PATIENT AFFECTED NO I ALSO CALLED THE CUSTOMER. THE RESULTS FOR THE DOCTOR WAS HELD BACK BY BIOLOGIST, SO ANTIBIOTIC THERAPY WAS NOT INITIATED. THEY ARE GOING TO REVIEW THEIR PROCEDURE OF PRELIMINARY REPORTER BASED ON GRAM STAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463557 ↗
• MalfunctionFeb 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE¿ SOY BROTH THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED A RATHER NASTY ISSUE TODAY REGARDING OUR TSBS. WE SAW GRAM NEG RODS IN A TISSUE WHICH GRAM SAID WAS NEGATIVE AND ALSO NOT CULTURED. THEN WE RETESTED THE TISSUE AND FOUND IT TO BE NEGATIVE AGAIN. THEN WE MADE A SPIN OF THE TSB TUBE AND A PART FROM THE FRIG (STILL UNOPENED) AND THESE WERE ALSO FOUND TO CONTAIN THE SAME GRAM NEGATIVE RODS. WE SUSPECT FATE DEPENDENT? HAVE YOU HAD ANY COMMENTS ON THIS? SEE PHOTOS AT THE BOTTOM OF THE EMAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375230 ↗
• MalfunctionJan 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATE MEDIA OCCURRED. SEVERAL CULTURES WERE REPORTED WITH NO SUBSEQUENT GROWTH ON THE PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE USED THIS BROTH FOR GRINDING OUR TISSUES FROM THE OPERATING ROOM. GRAM STAINS OF THE GROUND SPECIMEN SHOWED LARGE DECOLORIZING GRAM POSITIVE RODS WHICH WERE REPORTED IN A NUMBER OF CULTURES, WITH NO SUBSEQUENT GROWTH ON THE PLATES. WE DID A CYTOSPIN OF THE BROTH WHICH SHOWED THESE RODS IN THE UNINOCULATED TSB BROTH. I KNOW BD GUARANTEES STERILITY, BUT NOT THAT THERE WILL BE NO NON-VIABLE ORGANISMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16262095 ↗
• MalfunctionJan 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE¿ SOY BROTH THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES 2 SHIPMENTS WERE RECEIVED CONTAMINATED: LOT #S 2244933 AND 2272714.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108912 ↗
• MalfunctionJan 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE¿ SOY BROTH THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES 2 SHIPMENTS WERE RECEIVED CONTAMINATED: LOT #S 2244933 AND 2272714.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108860 ↗
• MalfunctionJul 14, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THAT RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE BROTH WAS CONTAMINATED WITH DEAD BACTERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019259 ↗
• MalfunctionMay 16, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING 100 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: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. ACCORDING TO THE CUSTOMER'S INFORMATION, NEGATIVE BACILLUS WAS FOUND TO HAVE GROWN DURING A GRAM STAINING PERFORMED DIRECTLY FROM THE BROTH. (B)(6) ON (B)(6) 2022. ON 05MAY2022/ (B)(4) - ADDITIONAL INFORMATION PROVIDED FROM TASK: DID THE CUSTOMER FIND BIOLOGICAL GROWTH - DID THE ORGANISM GROW ON THEIR MEDIA? YES OR NO? THEY DID NOT CULTURE THE MEDIA. BUT THEY ASSUMED THESE WERE NON-VIABLE ORGANISMS. IF NO THEN PLEASE CLARIFY IF WHAT THEY ARE SEEING ARE NON-VIABLES IN THE TUBE. WHEN SAMPLE IS PLATED THERE IS NO GROWTH SEEN. SINCE REPORTED DURING USE NEED THE FOLLOWING ANSWERED: WERE ANY ERRONEOUS RESULTS REPORTED ON ANY PATIENT SAMPLES? YES. IF SO WERE ANY PATIENTS TREATED BASED ON THE ERRONEOUS RESULTS? UNKNOWN. ANY OTHER PATIENT IMPACT? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413970 ↗
• MalfunctionMay 11, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND EXPERIENCING SEVEN OCCURRENCES OF CONTAINING NON-VIABLE CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT CONTAINS LARGE GRAM POSITIVE RODS (NON-VIABLES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360607 ↗
• MalfunctionApr 21, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 TUBE ARRIVES WITH CONTAMINATION IN 221716 LOT 2026705. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER RECEIVED 1 TUBE THAT WAS CONTAMINATED UPON ARRIVAL. TUBE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176718 ↗
• MalfunctionDec 1, 2021Contamination; False Positive Result; Contamination; False Positive Result

  IT WAS REPORTED THAT AFTER BD BBL¿ TRYPTICASE¿ SOY BROTH WERE CONTAMINATED. CUSTOMER INOCULATED 5 TUBES AND OBTAINED FALSE POSITIVE RESULT FOR GNR. CUSTOMER ALSO TESTED 3 UN-INOCULATED TUBES AND THEY ALSO HAD FALSE POSITIVE FOR GNR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTING CONTAMINATION WITH PRODUCT 221716 LOT 0174108 5 FROM PATIENT SAMPLES AND 3 CUSTOMER TESTED FROM UNINOCULATED TUBES. 8 TOTAL WHEN WAS THE CONTAMINATION OBSERVED? BEFORE OR AFTER INOCULATION/INCUBATION? BEFORE OR AFTER OPENING SLEEVES? PATIENT SAMPLES TUBES WERE INOCULATED AND INCUBATED AND THE ORGANISM WAS FOUND ON GRAM STAIN AFTER THAT. CUSTOMER ALSO DID GRAM STAIN ON UNINOCULATED TUBES AND FOUND ORGANISM. UPON VISUAL INSPECTION OF THE CONTAMINATED MEDIA WAS THE CONTAMINATION: BACTERIA OR FUNGI? BACTERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911535 ↗