BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL

    MDR report key: 12480522 · Received September 16, 2021

    Report

    Report Number
    12480522
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 13, 2021
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DYB
    UDI-DI
    00850004312025
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER TIP CRIMPING ON ITSELF UPON FEMORAL ACCESS INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381189 STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL INTRODUCER, CATHETER DYB FREUDENBERG MEDICAL, LLC SS085075M 0000177408 00850004312025

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA