BD BBL™ Brain Heart Infusion 220837Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30382902208373), received between Feb 1, 2023 and Aug 29, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922352 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892479 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892463 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892461 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892459 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892455 ↗
• MalfunctionAug 28, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ BRAIN HEART INFUSION, THERE WAS BIOLOGICAL CONTAMINATION OF 100 TUBES ACROSS THREE BATCH NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MICROSCOPIC CONTROL FROM A STERILE BOULLION REVEALED GRAM-NEGATIVE RODS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632740 ↗
• MalfunctionJun 30, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT WHILE USING BD BBL¿ BRAIN HEART INFUSION THERE WAS BACILLI CONTAMINATION ON THE SLIDE. ONE SLIDE WAS AFFECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REFER TO HAVE SEEN BACILLI ON SLIDE ALTHOUGH NOTHING GREW ON PLATES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243384 ↗
• MalfunctionJun 21, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ BRAIN HEART INFUSION TUBES HAD NONVIABLE CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE BHI TUBES FROM LOT 2124342, EXP. 2023-11-02 ARE CONTAMINATED WITH NONVIABLE GRAM BACILLI (RODS). THEY USE BHI TUBES TO RESUSPEND LAST DROPS OF RED BLOOD CELLS OBTAINED DURING TRANSFUSION REACTIONS AND CULTURE THE PELLET. ON THE GRAM, THEY OBSERVE VARIABLE GRAM BACILLI (RODS) BUT NOTHING GROWS. THEY INVESTIGATED AND FOUND THAT THE BHI TUBES CONTAIN ARTEFACTS OF DEAD BACTERIA WHICH DO NOT GROW BUT ARE VISIBLE ON THE GRAM. THEREFORE, THEY ARE NOTIFIED OF THE PRESENCE OF BACTERIA DURING THE GRAM STAIN, AND THIS IS VERY PROBLEMATIC FOR THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173485 ↗
• MalfunctionJun 16, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT BD BBL¿ BRAIN HEART INFUSION MEDIA WAS CONTAMINATED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VISIBLE CONTAMINATION. TUBES SHOW TURBIDITY WHEN DID THE INCIDENT OCCUR?: BEFORE USE UPDATE- 12/JUN/2023: CUSTOMER REFER TO HAVE SEEN BACILLI ON SLIDE ALTHOUGH NOTHING GREW ON PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148459 ↗
• MalfunctionJun 16, 2023Contamination; Contamination

  IT WAS REPORTED THAT BD BBL¿ BRAIN HEART INFUSION MEDIA WAS CONTAMINATED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAM-NEGATIVE RODS DETECTED MICROSCOPICALLY ON RECEIPT OF GOODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148322 ↗
• MalfunctionJun 15, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD BBL¿ BRAIN HEART INFUSION THERE WAS BIOLOGICAL CONTAMINATION. THIS OCCURRED ON SEVEN PLATES. THERE WAS NO PATIENT IMPACT REPORTED. GRAM STAIN WAS USED FOR CONFIRMATORY TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN ALL THE GRAM STAINS THAT WERE CREATED WHILE USING THE BROTH WITH LOT 2279210, GRAM-LABILE BACTERIA WERE FOUND WHICH COULD NOT BE CULTURED ON THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138243 ↗
• MalfunctionMar 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD BBL¿ BRAIN HEART INFUSION THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAM PREPARATION FROM STERILE BOULLION AS WELL AS FROM INOCULATED BOULLION NEGATIVE RODS SIGHTED. NO TURBIDITY OF THE BOULLION VISIBLE!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513248 ↗
• MalfunctionFeb 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD BBL¿ BRAIN HEART INFUSION UPON RECEIPT IT WAS VISUALLY CLOUDY SWIRLING IN BROTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATE CONTAMINATION= SLIGHTLY CLOUDY SWIRLING IN BROTH. USUALLY INDICATES BACTERIAL GROWTH = PLATED TO BLOOD AGAR = NO GROWTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277884 ↗