BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ AGAR, GRANULATED

    MDR report key: 15452467 · Received September 19, 2022

    Report

    Report Number
    1119779-2022-01209
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 11, 2022
    Report Date
    October 8, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    AFTER FURTHER REVIEW THIS MDR IS NOT REPORTABLE. THIS IS DCM AND LOOKING AT THE PHOTOS IT IS NOT BIOLOGICAL CONTAMINATION - BUT FM. THIS MDR CAN BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND SOME CONTAMINATION IN THE JARS FROM LOT 2038654 ON BD DIFCO¿ AGAR, GRANULATED. THERE WAS THREE OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: REPORTED CONTAMINATION LOT 2038654 AND FOUND SOME CONTAMINATION IN THE JARS AND ARE RETURNING A TOTAL OF 4 TO US THAT WE WOULD LIKE CREDIT FOR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND SOME CONTAMINATION IN THE JARS FROM LOT 2038654 ON BD DIFCO¿ AGAR, GRANULATED. THERE WAS THREE OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: " REPORTED CONTAMINATION LOT 2038654 AND FOUND SOME CONTAMINATION IN THE JARS AND ARE RETURNING A TOTAL OF 4 TO US THAT WE WOULD LIKE CREDIT FOR. ATTACHED IS A PICTURE OF THE CONTAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739787 BD DIFCO¿ AGAR, GRANULATED SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 2038654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown