BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR

    MDR report key: 17951411 · Received October 17, 2023

    Report

    Report Number
    1119779-2023-01134
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 21, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    KZJ
    UDI-DI
    30382902606834
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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 EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-01134 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USAGE OF BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THEY ENCOUNTERED A PERFORMANCE ISSUE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTED: IT WAS REPORTED BY CUSTOMER THAT GASPAK 260683 ANAEROBIC CONDITIONS NOT MAINTAINING FOR 6 DAYS. GASPAK 260683 PERFORMANCE PAST 2 DAYS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USAGE OF BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THEY ENCOUNTERED A PERFORMANCE ISSUE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTED: IT WAS REPORTED BY CUSTOMER THAT GASPAK 260683 ANAEROBIC CONDITIONS NOT MAINTAINING FOR 6 DAYS. GASPAK 260683 ANAEROBIC CONDITIONS NOT MAINTAINING FOR 6 DAYS. GASPAK 260683 PERFORMANCE PAST 2 DAYS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738358 BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382902606834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown