BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 18939747 · Received March 20, 2024

    Report

    Report Number
    2647876-2024-00059
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 22, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904422882
    PMA / PMN Number
    K970512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG 442288 BATCH NO. 3145910. CUSTOMER REPORTED A FALSE NEGATIVE. 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. THE ATTACHED PLOT SHOWS SOME INDICATION OF SIGNAL NOISE NEAR THE TIME OF DETECTION THAT MAY HAVE CONTRIBUTED TO THE FALSE POSITIVE.  NOISY SIGNAL CAN BE CAUSED BY ELECTRICAL, PHYSICAL OR ENVIRONMENTAL DISTURBANCES OF THE INSTRUMENT. COMPLAINT IS UNCONFIRMED. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: ONE ADDITIONAL CODE APPLIES; K970333. 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¿ MYCO/F LYTIC CULTURE VIALS, A FALSE NEGATIVE RESULT WAS OBTAINED WHEN TESTING THE BONE MARROW OF A PATIENT KNOWN TO HAVE DISSEMINATED TB. CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON IF THERE WAS PATIENT IMPACT OR ANY CHANGE IN TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS, A FALSE NEGATIVE RESULT WAS OBTAINED WHEN TESTING THE BONE MARROW OF A PATIENT KNOWN TO HAVE DISSEMINATED TB. CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON IF THERE WAS PATIENT IMPACT OR ANY CHANGE IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589054 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3145910 00382904422882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown