BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION CONNECTOR

    MDR report key: 20482245 · Received October 17, 2024

    Report

    Report Number
    MW5161231
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEAKAGE COMING FROM THE EXTENSION CONNECTOR WHILE INJECTING SALINE SMALL-BORE PRESSURE INFUSION EXT SET W/REMY MICRO LAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261188 EXTENSION CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. MC33038 14065651

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male