BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE TSA5% SB//LEVINE EMB

    MDR report key: 15460028 · Received September 20, 2022

    Report

    Report Number
    1119779-2022-01196
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 252258 LOT#2172382 WE CONFIRMED ISSUE AS A REPORT FROM PHOTO. THE ISSUE WAS CONTAMINATION. PHOTO SHOWED THE BACTERIA ON THE BLOOD AGAR. NO ISSUE IN RETENTION SAMPLE. NO ISSUE IN DEVICE HISTORY RECORD. ROOT CAUSE WAS UNDETERMINED. NO TREND. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 BD BBL¿ PLATE TSA5% SB//LEVINE EMB HAD FIVE PLATES CONTAMINATED WITH MOLD. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GET MOULDY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ PLATE TSA5% SB//LEVINE EMB HAD FIVE PLATES CONTAMINATED WITH MOLD. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GET MOLDY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751545 BD BBL¿ PLATE TSA5% SB//LEVINE EMB CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2172382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown