BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX AST BROTH, 4.5 ML

    MDR report key: 11495673 · Received March 16, 2021

    Report

    Report Number
    1119779-2021-00495
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460115
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR PHOENIX AST BROTH (246011) BATCH 0093336 THAT CONTAINED CONTAMINATED TUBES. SAMPLES WERE ORIGINALLY SENT BACK FROM THE CUSTOMER, HOWEVER THEY WERE SENT TO THE INCORRECT SITE. DURING TRANSFER OF THE SAMPLES FROM THE INCORRECT LOCATION TO SPARKS, THE SAMPLES WERE MISPLACED AND UNABLE TO BE LOCATED. IN ADDITION TO THE SAMPLES, 2 PHOTOS WERE ALSO PROVIDED BY THE CUSTOMER WHICH SHOWED FOREIGN MATTER IN THE TUBE. ADDITIONALLY, A RETENTION BOX (100 TUBES) FROM THIS COMPLAINT BATCH WAS VISUALLY INSPECTED FOR CONTAMINATED TUBES. ZERO OUT OF THE 100 TUBES INSPECTED WERE CONTAMINATED. BASED ON THE PHOTOS PROVIDED, THIS COMPLAINT IS CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THIS COMPLAINT BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 10 BD PHOENIX¿ AST BROTH, 4.5 ML CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10 BD PHOENIX¿ AST BROTH, 4.5 ML CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394147 BD PHOENIX AST BROTH, 4.5 ML SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246011 0093336 30382902460115

    Patients

    Seq Age Sex Outcome Treatment
    1