BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR

    MDR report key: 14322755 · Received May 7, 2022

    Report

    Report Number
    2647876-2022-00132
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 12, 2022
    Report Date
    June 28, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    00382902606833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 27-APR-2022. H6: INVESTIGATION SUMMARY A COMPLAINT INVESTIGATION, DUE TO LACK OF GROWTH AND BLACK DOTS ON GASPAK EZ ANAEROBE POUCH W INDICATOR CATALOG 260683 BATCH NO.: 2007649, WAS PERFORMED ON RETENTION SAMPLES AND RETURNED GOODS. THE INVESTIGATION REQUIRED TO PERFORM ANAEROBIC REDUCTION, MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST, VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. SINCE RETURNED GOOD WERE RECEIVED ALREADY ACTIVATED THEY WERE UNABLE TO BE FURTHER INVESTIGATED. PERFORMANCE TEST AS WELL AS VISUAL INSPECTION WAS NOT PERFORMED. LARGE DARK DOTS WERE OBSERVED ON ACTIVATED SACHET. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. BASED ON INFORMATION EVALUATED AND RESULTS OBTAINED, COMPLAINT IS UNABLE TO BE CONFIRMED FOR CONTAMINATION. COMPLAINT HAS BEEN CONFIRMED FOR A COSMETIC DEFECT BASED ON THE PHOTOS PROVIDED AND RETURNED SAMPLES. CONDENSATION, EXTRA MOISTURE IN THE BAG OR PLATE TEMPERATURE CHANGES CAN AFFECT APPEARANCE OF SACHETS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR MOLD CONTAMINATION 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: CUSTOMER REPORTS A LACK OF GROWTH WHEN USING GASPAK 260683. CUSTOMER ADDITIONALLY REPORTS THAT AFTER 2 DAYS OF INCUBATION THE SACHETS DISPLAY BLACK DOTS SIMILAR TO MOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR MOLD CONTAMINATION 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: CUSTOMER REPORTS A LACK OF GROWTH WHEN USING GASPAK 260683. CUSTOMER ADDITIONALLY REPORTS THAT AFTER 2 DAYS OF INCUBATION THE SACHETS DISPLAY BLACK DOTS SIMILAR TO MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889475 BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 2007649 00382902606833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown