BD BBL™ Trypticase™ Soy Broth 297354Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 30382902973547), received between Mar 10, 2021 and Nov 11, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (15 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TRYPTICASE¿ SOY BROTH, THE TUBE BROKE IN THE USER'S HAND, WHEN THEY WERE TIGHTENING THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524443 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 22922350 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 22922347 ↗
• MalfunctionFeb 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT A TUBE WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE CUSTOMER IS PREPARING FOR USE, IT IS FOUND THAT THE PRODUCT BOTTLE MOUTH CAP IS DAMAGED, THE FILLING VOLUME IS INSUFFICIENT, THE BACTERIA GROW, AND THE BOTTLE BODY HAS NO LABEL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754454 ↗
• MalfunctionSep 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THAT THERE WAS NO GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 ORGANISMS WERE NOT GROWING (IN-HOUSE ISOLATE: M. LUTEUS , EZ-ACCUSHOT: S. AUREUS AND G. STEAROTHERMOPHILUS) IN TSB BUT WAS GROWING WELL ON THE TSA INOCULATION VERIFICATION. IT WAS HER SECOND ATTEMPT USING THE EZ-ACCUSHOT AND FIRST ATTEMPT USING THE IN-HOUSE ISOLATE, YIELDING NO GROWTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777789 ↗
• MalfunctionAug 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY BROTH THE TUBE WAS CONTAMINATED AND APPEARED "CLOUDY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: ON (B)(6) 2023 DURING PRE USE INSPECTION 1 VIAL WITH CLOUDING WAS IDENTIFIED AND SORTED OUT. BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17580726 ↗
• MalfunctionJun 14, 2023Contamination; Contamination

  IT WAS REPORTED THAT 3 BD BBL¿ TRYPTICASE¿ SOY BROTH TUBES CONTAINED NONVIABLE CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JUST WANTED TO NOTIFY YOU OF ANOTHER RECURRENCE OF THE CONTAMINATION WITH THE BELOW LOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131281 ↗
• MalfunctionMar 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH MOLD APPEARED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING THAT THEY HAD MOLD APPEAR ON D14 ON ITEM 297354, LOT # 2293271, EXP: 17APR2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505132 ↗
• MalfunctionMar 8, 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 IS REPORTING 2 CONTAMINATED MEDIA FOR ITEM 297354, LOT #¿S 2146742 & 2209307.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504523 ↗
• MalfunctionJan 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH RESULTS INDICATE PARTICLE CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO MICROBIAL GROWTH HOWEVER RESULTS INDICATE PARTICLE CONTAMINATION. THERE IS NO DAMAGE NOTED TO THE TUBES ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134373 ↗
• MalfunctionDec 27, 2022Incorrect, 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 PRODUCT EXHIBITS LOW FILL VOLUME AND CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056977 ↗
• MalfunctionDec 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH HAVE MICROBIAL CONTAMINATED TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ABOUT 200 TUBES (2PK) ARE CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991947 ↗
• MalfunctionDec 15, 2022Incorrect, 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 FAILED GROWTH PROMOTION WITH S.AUREUS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT FAILED GROWTH PROMOTION WITH S.AUREUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991852 ↗
• MalfunctionDec 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION OCCURRED IN DEFECTIVE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE TUBE CONTAINED MEDIA THAT WAS CLOUDY AND OF LOW VOLUME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982579 ↗
• MalfunctionDec 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT EXHIBITS LOW FILL VOLUME AND CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906384 ↗
• MalfunctionNov 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  T WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH PERFORMANCE ISSUE INSUFFICIENT GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD PERFORMED GROWTH PROMOTION TESTING ON 2 LOTS OF CAT#297354 MEDIA, BD BBL TRYPTICASE SOY BROTH, 100X10ML USING STAPHYLOCOCCUS AUREUS FROM BIOBALL NCTC 10788 AND MICROBIOLOGICS ACCUSHOTS ATCC 6538, AND WE WERE UNABLE TO OBTAIN ANY GROWTH IN THE MEDIA. WOULD LIKE TO CHECK IF ANY OF THE OTHER COMPANIES FEEDBACK TO YOU ON THIS ISSUE? KINDLY ADVISE SOON. TROUBLESHOOTING DONE: - ANALYSTS TECHNIQUE (STILL OCCURS WHEN EXPERIENCED ANALYSTS RUNS THE TEST) - THE BRAND OF MICROORGANISMS (SAME OUTCOME WITH DIFFERENT BRANDS OF SA WERE USED. OTHER MEDIA DO NOT HAVE RECOVERY ISSUE). - LOT SPECIFICITY (AT LEAST 2 LOTS OF TSB FROM BD HAVE HAD THIS ISSUE). - I UNDERSTAND THAT MANUFACTURERS WOULD HAVE ESTABLISHED ITS PRODUCT SHELF LIFE THROUGH RIGOROUS TESTING AT DIFFERENT LIFECYCLE OF THE PRODUCT. BESIDES THE INITIAL RELEASE TESTING FOR EACH ROUTINE LOT, HOW OFTEN IS THIS BEING VERIFIED ?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811034 ↗
• MalfunctionJul 7, 2022Contamination; Contamination

  IT WAS REPORTED THAT 100 TUBES OF BD BBL¿ TRYPTICASE¿ SOY BROTH WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION. RECEIVED ON (B)(6) 2022. BOTH BOXES THAT WE RECEIVED SEEM TO HAVE BEEN CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946577 ↗
• MalfunctionJun 21, 2022Contamination; Contamination

  IT WAS REPORTED THAT 100 TUBES OF BD BBL¿ TRYPTICASE¿ SOY BROTH WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 297354 TUBES FROM LOT 2062203. THEY FOUND THE CONTAMINATION DURING TESTING OF BIOLOGICAL INDICATORS. HOW MANY INDIVIDUAL TUBES DID YOU FIND TO BE CONTAMINATED?1 FULL RACK (100CT). WHEN WAS THE CONTAMINATION OBSERVED? BEFORE OR AFTER INOCULATION/INCUBATION? TURBIDITY AND THE PRESENCE OF WHAT APPEARED TO BE BACTERIAL CELLS WAS OBSERVED ON TUBES THAT HAD BEEN USED/INCUBATED FOR AN ASSAY. IT WAS LATER DISCOVERED ON THE ENTIRETY OF THE 100CT RACK THAT THEY HAD BEEN TAKEN FROM. WAS THE CONTAMINATION BIOLOGICAL IN NATURE OR FOREIGN MATTER? IT APPEARED BIOLOGICAL (BACILLI) MICROSCOPICALLY. ATTEMPTS TO ISOLATE AND CULTURE WERE UNSUCCESSFUL. IF BIOLOGICAL, WAS THE ORGANISM STAINED OR IDENTIFIED? IF IDENTIFIED, WHAT WAS THE SPECIES AND CONFIDENCE LEVEL OF THE IDENTIFIED SPECIES? SEE ABOVE. GRAM STAIN RESULT: GRAM-POSITIVE ROD. DNA SEQUENCING WAS ALSO UNSUCCESSFUL. WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758280 ↗
• MalfunctionJun 10, 2022Contamination; Contamination

  IT WAS REPORTED THAT ONE BD BBL¿ TRYPTICASE¿ SOY BROTH TUBE WAS FOUND TO BE CONTAMINATED BEFORE USE. ADDITIONAL TESTING INDICATED THAT 3 ADDITIONAL TUBES WERE ALSO CONTAMINATED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION ID WAS BACILLUS MEGATERIUM/ARYABHATTAI. APPROXIMATE NUMBER OF CONTAMINATED PRODUCTS? 1 TUBE NOTED DURING PRE-INSPECTION PERFORMED DUE TO SUSPECTED CONTAMINATION, AND 3 TUBES DETECTED DURING TESTING. WAS THE CONTAMINATION NOTICED BEFORE OR AFTER USE? BOTH. IF AFTER USE, WAS ANY PATIENT REPORTS REPORTED AND ANY ADVERSE EFFECTS? NO. WAS THE CONTAMINATION GRAM STAINED? YES GRAM POSITIVE ROD FOR TUBE FOUND DURING TESTING (PRESTIA SP.) GRAM NEGATIVE ROD (ACINETOBACTER SP). WHAT WAS THE METHOD USED IN IDENTIFYING THE CONTAMINATION? GENETIC SEQUENCING. TO CLARIFY ¿ NO PATIENT SAMPLES WERE INVOLVED. HOWEVER, A LABORATORY INVESTIGATION WAS PERFORMED FOR CONTAMINATION OBSERVED IN THE TESTING OF A PRODUCT SAMPLE. THIS INVESTIGATION DETERMINED THE ROOT CAUSE OF THE CONTAMINATION OBSERVED IN TESTING A PRODUCT SAMPLE TO BE CONTAMINATION FROM THE MEDIA, SO THERE WAS A ¿FALSE POSITIVE¿ EVENT IN LABORA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658888 ↗
• MalfunctionJun 1, 2022Contamination; Contamination

  IT WAS REPORTED WHILE TESTING WITH BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS DISCOVERED BEFORE USE. 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 UPON REMOVAL OF NESTED TUBES FROM BOX, A TUBE WITH TURBIDITY AND PARTICULATES WAS FOUND. THIS WAS UNOPENED BY THE QC MICRO TEAM, CUSTOMER PROBLEM: COMPLAINT RECEIVED VIA VWR ON BEHALF OF THEIR CUSTOMER AND STATES THE FOLLOWING: "UPON REMOVAL OF NESTED TUBES FROM BOX, A TUBE WITH TURBIDITY AND PARTICULATES WAS FOUND. THIS WAS UNOPENED BY THE QC MICRO TEAM, 1. OF THE 20 PACKS, ONLY 6 HAVE BEEN INSPECTED AND 1 FOUND WITH THE DEFECT. 2. QUANTITY RECEIVED AND QUANTITY AFFECTED: 20 PACKS RECEIVED, 1 TUBE AFFECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568501 ↗
• MalfunctionMay 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THE CUSTOMER RECEIVED 3 BOXES THAT WERE CONTAMINATED. THERE IS NO CONFIRMATORY TESTING REPORTED. THERE IS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED, "WHEN WE RECEIVED THE 3 REMAINING BOXES ON (B)(6) 2022, EACH HAD SOME MEDIA TUBES THAT WERE CONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459138 ↗
• MalfunctionMay 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THE CUSTOMER RECEIVED 3 BOXES THAT WERE CONTAMINATED. THERE IS NO CONFIRMATORY TESTING REPORTED. THERE IS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED, "WHEN WE RECEIVED THE 3 REMAINING BOXES ON (B)(6) 2022, EACH HAD SOME MEDIA TUBES THAT WERE CONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458761 ↗
• MalfunctionApr 8, 2022Contamination; Contamination

  IT WAS REPORTED THAT THERE ARE VISIBLE SIGNS OF CONTAMINATION WITH MICROBIAL GROWTH, WITHIN BD BBL¿ TRYPTICASE¿ SOY BROTHTUBE. CONFIRMATORY TESTING PERFORMED: ¿THE MICROBIAL IDENTIFICATION OF THIS MICROORGANISM IS ACINETOBACTER SPECIES.¿ THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿TO BE CLEAR: 1 TUBE WAS FOUND TO BE CONTAMINATED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059875 ↗
• MalfunctionJan 14, 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 SIX OCCURRENCES OF PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IN SCOPE OF PRODUCT¿S QUALIFICATION, END OF PRODUCT¿S EXPIRY DATE; WE PERFORM THE QUALITY TESTS ON PRODUCTS AGAIN. (THE AIM OF PRODUCTS QUALIFICATION IS TO CONFIRM THE USABILITY OF PRODUCTS ON THE EXPIRY DAY BECAUSE OF TEST¿S INCUBATION PERIOD, SO HAVE TO CHECK PRODUCT¿S QUALITY) AND WE TESTED THEM AT THE END OF THE EXPIRY DATE. EXCEPT PH TEST, ALL QUALITY CONTROL TESTS RESULTS ARE SUITABLE ACCORDING TO THE CERTIFICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260637 ↗
• MalfunctionDec 14, 2021Contamination; Contamination

  IT WAS REPORTED THAT ONE BD BBL¿ TRYPTICASE¿ SOY BROTH TUBE WAS CONTAMINATED WITH BACTERIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS TUBE WITH CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005014 ↗