BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST BROTH

    MDR report key: 13260642 · Received January 14, 2022

    Report

    Report Number
    1119779-2022-00029
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 29, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460030
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1070156. MEDICAL DEVICE EXPIRATION DATE: 2022-03-04. DEVICE MANUFACTURE DATE: 2021-03-11. MEDICAL DEVICE LOT #: 1124222. MEDICAL DEVICE EXPIRATION DATE: 2022-04-29. DEVICE MANUFACTURE DATE: 2021-05-04. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS COMPLAINT IS FOR CONTAMINATED PHOENIX AST BROTH TUBES (246003) BATCHES 1070156 AND 1124222. THE CUSTOMER DID PROVIDE PHOTOS FOR INVESTIGATION. THE PHOTOS SHOW SOME FORM OF BIOLOGICAL OR FUNGAL CONTAMINATION IN THE BROTH TUBES. THIS COMPLAINT IS CONFIRMED. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCHES. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH 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 HAS BEEN REPORTED THAT THE BD PHOENIX¿ AST BROTH HAS BEEN FOUND EXPERIENCING 18 OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AST BROTHS WERE SHOWING FUNGAL CONTAMINATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD PHOENIX¿ AST BROTH HAS BEEN FOUND EXPERIENCING 18 OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AST BROTHS WERE SHOWING FUNGAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730378 BD PHOENIX¿ AST BROTH SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 246003 SEE H.10 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown