BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12652241 · Received October 18, 2021

    Report

    Report Number
    2647876-2021-00216
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 19, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2647876-2021-00216 WAS SENT IN ERROR. IT WAS DETERMINED THAT THIS PATIENT WAS NOT AFFECTED BY PART# 442023, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING ON BIOFIRE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE FOR ACINETOBACTER AND WAS OBTAINED. CONFIRMATORY CULTURE WAS PERFORMED AND THERE WAS NO GROWTH FOR ACINETOBACTER. THE RESULT WAS REPORTED. CUSTOMER HAS NOT CONFIRMED IF TREATMENT FOR ACINETOBACTER WAS PROVIDED TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 6 OF 7 IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. PLEASE PROVIDE THE DATE THIS PATIENT WAS TESTED ON THE BIOFIRE: (B)(6) 2021 WAS BIOFIRE RESULT DUAL POSITIVE? ACINETOBACTER AND E.COLI WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THIS BOTTLE? YES. IF SO WHAT WAS THE ORGANISM REPORTED? GRAM NEGATIVE RODS DID ANY ORGANISM GROW IN CULTURE? E. COLI WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES WAS THE PATIENT TREATED FOR THE ACINTOBACTER? CUSTOMER UNSURE BUT WILL FOLLOW UP AFTER SPEAKING WITH THE PHARMACY IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? PENDING FOLLOW UP WITH CUSTOMER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING ON BIOFIRE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE FOR ACINETOBACTER AND WAS OBTAINED. CONFIRMATORY CULTURE WAS PERFORMED AND THERE WAS NO GROWTH FOR ACINETOBACTER. THE RESULT WAS REPORTED. CUSTOMER HAS NOT CONFIRMED IF TREATMENT FOR ACINETOBACTER WAS PROVIDED TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT 6 OF 7 IT WAS REPORTED THAT ACINETOBACTER RESULTING ON BIOFIRE FOR POSITIVE 442023 BOTTLES LOT 1160562, BUT IT DOES NOT GROW IN CULTURE. PLEASE PROVIDE THE DATE THIS PATIENT WAS TESTED ON THE BIOFIRE: (B)(6) 2021. WAS BIOFIRE RESULT DUAL POSITIVE? ACINETOBACTER AND E.COLI WAS ANY ORGANISM SEEN ON THE GRAM STAIN FOR THIS BOTTLE? YES. IF SO WHAT WAS THE ORGANISM REPORTED? GRAM NEGATIVE RODS. DID ANY ORGANISM GROW IN CULTURE? E. COLI. WAS THE ACINETOBACTER REPORTED OUT FOR THIS PATIENT? YES. WAS THE PATIENT TREATED FOR THE ACINTOBACTER? CUSTOMER UNSURE BUT WILL FOLLOW UP AFTER SPEAKING WITH THE PHARMACY. IF SO WERE THERE ANY ADVERSE REACTIONS TO THE TREATMENT? PENDING FOLLOW UP WITH CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549613 BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1097815 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1