BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR

    MDR report key: 14877511 · Received June 30, 2022

    Report

    Report Number
    2647876-2022-00164
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902606834
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION; DUE TO ANAEROBIC CONDITIONS NOT MET USING GASPAK EZ ANAEROBE POUCH W INDICATOR CATALOG 260683 BATCH NO.: 1036144, WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM ANAEROBIC REDUCTION, MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST, VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. INCOMING AND BATCH RECORD REVIEW DID NOT SHOWED ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. INSTRUCTION FOR USE (IFU) ESTABLISHED INSTRUCTION ON RESULTS EVALUATION. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR AN ATYPICAL REACTION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ANAEROBIC INDICATORS ARE CHECKED 4-24HOURS TO ENSURE ANAEROBIC CONDITIONS ARE ACHIEVED. HOWEVER IT HAS BEEN NOTED THAT ANAEROBIC CONDITIONS WERE ACHIEVED ON THIS CHECK AND SOMEWHERE AFTER THE 24HOUR CHECK AND THE FINAL READ THE INDICATOR SHOWS THAT ANAEROBIC CONDITIONS WERE NOT MET. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR AN ATYPICAL REACTION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ANAEROBIC INDICATORS ARE CHECKED 4-24HOURS TO ENSURE ANAEROBIC CONDITIONS ARE ACHIEVED. HOWEVER IT HAS BEEN NOTED THAT ANAEROBIC CONDITIONS WERE ACHIEVED ON THIS CHECK AND SOMEWHERE AFTER THE 24HOUR CHECK AND THE FINAL READ THE INDICATOR SHOWS THAT ANAEROBIC CONDITIONS WERE NOT MET. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396404 BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 260683 1036144 30382902606834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown