BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ CAMPY CONTAINER SYSTEM SACHETS

    MDR report key: 25071616 · Received May 4, 2026

    Report

    Report Number
    2647876-2026-00048
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902606803
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. D4. MEDICAL DEVICE LOT#: UNKNOWN. E1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED; THEREFORE, MD WAS USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION WAS PERFORMED, DUE TO CAMPY ISSUE SHOWING FALSE POSITIVE WITH GASPAK EZ CAMPY CONTAINER CATALOG 260680. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR FUNCTIONALITY (MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST, CONDENSATE TIME), VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. RETENTION SAMPLES UNABLE TO BE TESTED. BATCH NUMBER WAS NOT RECEIVED. RETURNED GOODS NOT RECEIVED FOR INVESTIGATION. INCOMING AND BATCH RECORD REVIEW UNABLE TO BE PERFORMED SINCE BATCH NUMBER WAS NOT PROVIDED BY CUSTOMER. FROM A PERIOD OF 1 YEAR (APR2025 TO 29APR2026) QUALITY NOTIFICATION (QN) SYSTEM WAS EVALUATED. NO QNS WERE ISSUED DUE TO PRODUCT PERFORMANCE FAILURE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED. NO TREND WAS FOUND RELATING TO THE CLAIM REPORTED. 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 CAMPY CONTAINER SYSTEM SACHETS, A FALSE POSITIVE RESULT WAS OBTAINED ON UNSPECIFIED NUMBER OF PATIENTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470827 BD GASPAK¿ EZ CAMPY CONTAINER SYSTEM SACHETS DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. UNKNOWN 30382902606803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown