BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX AST BROTH

    MDR report key: 12339820 · Received August 18, 2021

    Report

    Report Number
    1119779-2021-01403
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 22, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460030
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS COMPLAINT IS FOR CONTAMINATED TUBES OF PHOENIX AST BROTH (246003) BATCH 1112953. THE CUSTOMER PROVIDED NO PHOTOS OR RETURNS FOR INVESTIGATION. TO INVESTIGATE, 100 RETENTION TUBES FROM THE COMPLAINT BATCH WERE EVALUATED MANUALLY VISUALLY INSPECTED AND EVALUATED FOR ANY CONTAMINATION. 0/100 TUBES WERE OBSERVED FOR CONTAMINATION. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A LABORATORY TEST WAS USED TO CONFIRM THE CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BOX OF BD PHOENIX¿ AST BROTH (8 ML) - REF. (B)(4) - LOT. 1112953 - RECEIVED CONTAINS CONTAMINATED BOTTLES".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT 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 · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A LABORATORY TEST WAS USED TO CONFIRM THE CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BOX OF BD PHOENIX¿ AST BROTH (8 ML) - REF. (B)(4), LOT. 1112953, RECEIVED CONTAINS CONTAMINATED BOTTLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235073 BD PHOENIX AST BROTH SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 246003 1112953 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1