BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 18022572 · Received October 27, 2023

    Report

    Report Number
    2647876-2023-00378
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    July 1, 2023
    Report Date
    November 23, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG 442023, BATCH NO. 2326488. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. THE BATCH HISTORY RECORD WAS NOT REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: ONE ADDITIONAL CODE APPLIES; K222591. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE. THIS IS A REPORT OF ONE OCCURRENCE, AND PATIENT TREATMENT NOT AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) CATALOG NUMBER? RFIT-ASY-0147. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? LOT: 102123, LOT: 662033, LOT: 1371623, LOT: 1901123. WHAT RESULTS WERE REPORTED TO CLINICIANS AND WAS PATIENT TREATMENT AFFECTED IN RESPONSE? C.TROP NOT REPORTED AND PATIENT TREATMENT NOT AFFECTED BACTEC 442023_2326488 MOLECULAR FALSE POSITIVE WITH C.TROP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE. THIS IS A REPORT OF ONE OCCURRENCE, AND PATIENT TREATMENT NOT AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) CATALOG NUMBER? RFIT-ASY-0147. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? LOT: 102123 LOT: 662033 LOT: 1371623 LOT: 1901123 WHAT RESULTS WERE REPORTED TO CLINICIANS AND WAS PATIENT TREATMENT AFFECTED IN RESPONSE? C.TROP NOT REPORTED AND PATIENT TREATMENT NOT AFFECTED BACTEC 442023_2326488 MOLECULAR FALSE POSITIVE WITH C.TROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434226 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 2326488 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown