BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17795412 · Received September 21, 2023

    Report

    Report Number
    2647876-2023-00168
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 2, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2647876-2023-00168 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    REPORT 6 OF 7 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 6. 1241823 WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 6. KLEBSIELLA PNEUMONIAE GROUP + CANDIDA TROPICALIS WHAT ORGANISMS GREW ON CULTURE PLATE? 6. KLEBSIELLA PNEUMONIAE GROUP.

    Description of Event or Problem · 0

    REPORT 6 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 6. 1241823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 6. KLEBSIELLA PNEUMONIAE GROUP + CANDIDA TROPICALIS. WHAT ORGANISMS GREW ON CULTURE PLATE? 6. KLEBSIELLA PNEUMONIAE GROUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712352 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown