BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 11278498 · Received February 4, 2021

    Report

    Report Number
    11278498
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    US ENDOSCOPY
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STERIS IRRIGATION KIT REF # 00711556, LOT 2008099, EXPIRATION DATE 8/24/2021. IT WOULD NOT INSUFFLATE THE COLON. WE TRIED 3 DIFFERENT IRRIGATION KITS, BOTH PRIOR TO THIS CASE THE RED CAP THAT GOES ON THE WATER BOTTLE HAD A LEAK COMING FROM THE LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175914 NA ENDOSCOPE INTRODUCER KIT NWU US ENDOSCOPY 00711556 2009099

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA