BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL PRODUCT / PICC LINE WIRE

    MDR report key: 10816276 · Received November 9, 2020

    Report

    Report Number
    MW5097744
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 5, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING PICC LINE PLACED IN RIGHT ARM. DURING PROCEDURE, PICC LINE WIRE BECAME LODGED INTO SCAR TISSUE. DURING ATTEMPT TO PULL WIRE BACK, IT UNRAVELED. AFTER SEVERAL ATTEMPTS, ABLE TO RETRIEVE WIRE. WIRE SAVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271976 COOK MEDICAL PRODUCT / PICC LINE WIRE WIRE, GUIDE CATHETER DQX COOK MEDICAL LLC G05183-PMG-18SP-60-COPE 13294543

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR