BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR

    MDR report key: 12025877 · Received June 18, 2021

    Report

    Report Number
    3008352382-2021-00166
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902600016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A COMPLAINT INVESTIGATION FOR GASPAK EZ ANAEROBE CONTAINER W INDICATOR BATCH NO.: 0335627 WAS PERFORMED ON RETENTION SAMPLES AND RETURNED GOODS. THE INVESTIGATION REQUIRED TO PERFORM ANAEROBIC REDUCTION, MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST, CONDENSATE TIME, VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. RETURNED GOODS AND RETENTION SAMPLES PERFORMED AS EXPECTED. BROWN SPECK OBSERVED ON RETENTION SAMPLES AND RETURNED GOODS DURING THE VISUAL INSPECTION. HOWEVER, THIS DOES NOT AFFECT THE PRODUCT PERFORMANCE. REFER TO SUPPLIER LETTER ATTACHED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 6 BD GASPAK¿ EZ ANAEROBE CONTAINER 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: "IN TERMS OF THE SACHETS THEY APPEAR TO BE CONTAMINATED PRIOR TO BEING USED. THEY LOOK MOULDY TO ME FROM THE IMAGES & THE CUSTOMER SAID THEY APPEARED TO BE CONTAMINATED PRIOR TO USE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/ OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 6 BD GASPAK¿ EZ ANAEROBE CONTAINER 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: "IN TERMS OF THE SACHETS THEY APPEAR TO BE CONTAMINATED PRIOR TO BEING USED. THEY LOOK MOULDY TO ME FROM THE IMAGES & THE CUSTOMER SAID THEY APPEARED TO BE CONTAMINATED PRIOR TO USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924005 BD GASPAK EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 260001 0335627 30382902600016

    Patients

    Seq Age Sex Outcome Treatment
    1