BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE TSA5% SB//LEVINE EMB

    MDR report key: 15432980 · Received September 15, 2022

    Report

    Report Number
    1119779-2022-01197
    Event Type
    Malfunction
    Date Received
    September 15, 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

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 252258 LOT#2130468 WE CONFIRMED ISSUE AS A REPORT FROM PHOTO. THE ISSUE WAS CONTAMINATION. PHOTO SHOWED THE BACTERIA ON THE BLOOD AGAR 1CFU EACH. LOT WAS EXPIRED, WE COULDN'T TEST RETENTION SAMPLE. NO ISSUE IN DHR. NO TREND. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ PLATE TSA5% SB//LEVINE EMB HAD BIOLOGICAL CONTAMINATION- BACTERIAL, FUNGAL, NON-VIABLE. THERE WAS THREE OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: GET MOULDY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ PLATE TSA5% SB//LEVINE EMB HAD BIOLOGICAL CONTAMINATION- BACTERIAL, FUNGAL, NON-VIABLE. THERE WAS THREE OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "GET MOULDY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651839 BD BBL¿ PLATE TSA5% SB//LEVINE EMB CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2130468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown