BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR

    MDR report key: 17647305 · Received August 29, 2023

    Report

    Report Number
    2647876-2023-00112
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 14, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902600016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 SACHETS DON'T PRODUCE ANAEROBIC CONDITION WHEN USING GASPAK EZ ANAEROBE CONTAINER W INDICATOR CATALOG 260001 BATCH NO.: 2276730 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM ANAEROBIC REDUCTION, MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST, CONDENSATE TIME, 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 SHOW ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. A VERY LIGHT BLUE INDICATOR PILL WAS OBSERVED. THE COLOR APPRECIATION COULD BE AFFECTED DUE TO THE ANGLE OF THE PICTURE OR PICTURE'S ILLUMINATION. ONLY ONE SACHET IS OBSERVED. IT COULD NOT BE CONFIRMED THE QUANTITY OF SACHET USED BY JAR TO ASSURE IFU INSTRUCTIONS WERE FOLLOWED. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. IFU ESTABLISHED INSTRUCTION FOR PRODUCT TESTING AND 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 CONTAINER SYSTEM WITH INDICATOR, 20 SACHETS DON'T PRODUCE AN ANEROBIC CONDITION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SACHETS DON'T PRODUCE ANAEROBIC CONDITION. THE CUSTOMER PUT ONE SACHET WITH INDICATOR INTO A JAR, AFTER A NIGHT THEY WAS NOTICE THE INDICATOR STAY BLUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR, 20 SACHETS DON'T PRODUCE AN ANEROBIC CONDITION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SACHETS DON'T PRODUCE ANAEROBIC CONDITION. THE CUSTOMER PUT ONE SACHET WITH INDICATOR INTO A JAR, AFTER A NIGHT THEY WAS NOTICE THE INDICATOR STAY BLUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815924 BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 2276730 30382902600016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown