BD BACTEC™ Peds Plus™/ F Culture Vials 442194Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382904421946), received between May 14, 2018 and Mar 1, 2022 — classified as 2 deaths, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Contamination; Contamination

  IT WAS REPORTED WHEN USING THE BD BBL¿ VDRL ANTIGEN THERE WAS CONTAMINATION; BIOLOGICAL CONTAMINATION, BACTERIAL, FUNGAL, NON VIABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS POSSIBLE CONTAMINATION WITH BACTEC 442194 BOTTLE. THE BOTTLE GREW THE SAME ORGANISM WHICH WAS NOT EXPECTED. THEY HAD AN ADDITIONAL 6 BOTTLES TESTS FROM THE SAME LOT NUMBER BUT NONE OF THEM WERE POSITIVE FOR THE BACTERIA ISOLATED FROM THE OTHER TWO BOTTLES. CUSTOMER DID NOT PROVIDE THE ISOLATE NAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13641142 ↗
• MalfunctionMar 1, 2022Contamination; Contamination

  IT WAS REPORTED WHEN USING THE BD BBL¿ VDRL ANTIGEN THERE WAS CONTAMINATION; BIOLOGICAL CONTAMINATION, BACTERIAL, FUNGAL, NON VIABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS POSSIBLE CONTAMINATION WITH BACTEC 442194 BOTTLE. THE BOTTLE GREW THE SAME ORGANISM WHICH WAS NOT EXPECTED. THEY HAD AN ADDITIONAL 6 BOTTLES TESTS FROM THE SAME LOT NUMBER BUT NONE OF THEM WERE POSITIVE FOR THE BACTERIA ISOLATED FROM THE OTHER TWO BOTTLES. CUSTOMER DID NOT PROVIDE THE ISOLATE NAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13641024 ↗
• MalfunctionAug 6, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN 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: "THE CUSTOMER COMPLAINS ABOUT A HIGH NUMBER OF FALSE POSITIVE BLOOD CULTURE BOTTLES ON HIS FX 400 SOLUTION. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292032 ↗
• MalfunctionJul 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GRAM POSITIVE RODS WERE SEEN IN THE GRAM STAIN ON ALL BOTTLES, PER CUSTOMER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147609 ↗
• MalfunctionJun 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS 100 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A SUBCULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RANDOMLY SOME BOTTLES ARE GIVING FALSE POSITIVE RESULTS WHEN DO SUBCULTURE IT WAS NO GROWTH ON MEDIA ADDITIONAL INFORMATION FROM TASK: WERE ANY ERRONEOUS RESULTS REPORTED? NO IF SO - WAS ANY TREATMENT CHANGED DUE TO THE ERRONEOUS RESULTS REPORTED? NO "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005339 ↗
• MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490582 ↗
• MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH A BD BACTEC¿ PEDS PLUS¿ / F CULTURE VIALS. A "FALSE" LABEL WAS APPLIED TO BOTTLE OVER THE EXPIRATION DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11318702 ↗
• InjuryJun 1, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT BIOFIRE IDENTIFIED PROTEUS IN A POSITIVE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIAL. THE PATIENT IS (B)(6) IN AGE AND HAS BEEN IN THE NICU SINCE BIRTH. THE BIOFIRE RESULTS WERE REPORTED TO THE CAREGIVER, AND THE PATIENT WAS TREATED WITH GENTAMICIN AND VANCOMYCIN BASED ON THE BIOFIRE RESULTS. PER THE CUSTOMER, THE PATIENT IS IN CRISIS IN THE NICU.

  Patient problems: Unspecified Infection

  MAUDE report 7562741 ↗
• DeathJun 1, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BIOFIRE IDENTIFIED PROTEUS IN A POSITIVE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIAL WITH RESULTS BEING REPORTED BEFORE THE PATIENT EXPIRED. THE PATIENT WAS A FEW WEEKS IN AGE AND HAD BEEN IN THE NICU FOR THE E. COLI INFECTION SINCE BIRTH. THE CAREGIVERS WERE AWARE THAT THE PATIENT HAD E.COLI PRIOR TO RECEIVING THE BIOFIRE RESULTS. PER THE CUSTOMER, THE PATIENT¿S DEATH WAS NOT DUE TO ANY CHANGES IN TREATMENT AS A RESULT OF THE BIOFIRE RESULTS.

  Patient problems: Bacterial Infection; Death

  MAUDE report 7562719 ↗
• DeathJun 1, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT BIOFIRE IDENTIFIED PROTEUS IN A BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIAL WITH RESULTS BEING REPORTED OUT AFTER THE PATIENT EXPIRED. THE PATIENT WAS THREE MONTHS IN AGE AND HAD BEEN IN THE NICU FOR THE INFECTION SINCE BIRTH. THE CAREGIVERS WERE AWARE THAT THE PATIENT HAD E.COLI PRIOR TO RECEIVING THE BIOFIRE RESULTS. THE PATIENT WAS TREATED WITH GENTAMICIN AND VANCOMYCIN.

  Patient problems: Death

  MAUDE report 7562714 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NURSE RECEIVED A DIRTY NEEDLE STICK WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS. NO BLOOD-BORNE DISEASES WERE FOUND IN PATIENT¿S BLOOD, SO NO NEED TO TREAT THE NURSE.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 7511120 ↗