BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE)

    MDR report key: 16206594 · Received January 19, 2023

    Report

    Report Number
    1119779-2023-00039
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00039 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE) THAT THERE WAS INSUFFICIENT GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS STATED THAT BACTERIAL GROWTH HAS BEEN INSUFFICIENT AFTER SWITCHING TO THE CURRENT LOT (1155481).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE) THAT THERE WAS INSUFFICIENT GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS STATED THAT BACTERIAL GROWTH HAS BEEN INSUFFICIENT AFTER SWITCHING TO THE CURRENT LOT (1155481).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113242 BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE) SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 1155481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown