BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM

    MDR report key: 24910863 · Received April 17, 2026

    Report

    Report Number
    2647876-2026-00026
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902606841
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION WAS PERFORMED DUE TO PROBLEM WITH GENERATE CO2 ENVIRONMENT WITH GASPAK EZ CO2 POUCH CATALOG 260684, BATCH NO.: 5303157 ON RETENTION SAMPLES AND RETURNED GOODS. THE INVESTIGATION REQUIRED TO PERFORM FUNCTIONAL TEST (MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST), VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. FUNCTIONAL TEST ON RETENTION SAMPLES AND RETURNED GOODS SHOWED SATISFACTORY RESULTS ON MICROBIOLOGICAL PERFORMANCE AND UNSATISFACTORY RESULTS ON GAS CONCENTRATION TEST. LOW CO2 LEVEL OBSERVED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. INCOMING RECORD NOT AVAILABLE, LOT RECEIVED UNDER SKIP LOT PROGRAM. A COMPLAINT HISTORY REVIEW WAS CONDUCTED. NO TREND WAS FOUND RELATING TO THE INCIDENT LOT NUMBER. HOWEVER, A TREND WAS IDENTIFIED DUE TO CUSTOMER CLAIM. COMPLAINT IS CONFIRMED. THE SUPPLIER HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THIS SITUATION THROUGH CORRECTIVE AND PREVENTIVE ACTIONS PROCESS. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM, THE CUSTOMER NOTICED THE SACHETS ARE INTERMITTENTLY FAILING TO GENERATE THE APPROPRIATE CO2 ENVIRONMENT ON UNSPECIFIED NUMBER OF PATIENT SAMPLES. HOWEVER, WHEN THE CUSTOMER TESTED A DIFFERENT LOT FROM A SISTER HOSPITAL, THE SACHETS WORKED AS EXPECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34531 BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 5303157 30382902606841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown