BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TAXO¿ A

    MDR report key: 20763423 · Received November 22, 2024

    Report

    Report Number
    2647876-2024-00161
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTO
    UDI-DI
    30382902315521
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO NO INHIBITION ZONE WITH BACITRACIN TAXO A CATALOG 231552 BATCH NO.: 4023697 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    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 WHILE USING AN UNSPECIFIED NUMBER OF BD BBL¿ TAXO¿ A, DISCS, THERE IS NO ZONE OF INHIBITION WHEN TESTING WITH STREP PYOGENES SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED NUMBER OF BD BBL¿ TAXO¿ A, DISCS, THERE IS NO ZONE OF INHIBITION WHEN TESTING WITH STREP PYOGENES SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068554 BD BBL¿ TAXO¿ A DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION JTO BECTON DICKINSON CARIBE LTD. 4023697 30382902315521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown