BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE PEEL-AWAY INTRODUCER (INSIDE PICC PACK)

    MDR report key: 2781918 · Received October 4, 2012

    Report

    Report Number
    MW5027196
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 4, 2012
    Manufacturer
    COOK MEDICAL INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ULTRASOUND GUIDED PICC LINE WAS INSERTED INTO PATIENT'S LEFT UPPER ARM USING AN INTRODUCER (WITHOUT EVENT) AS THE PRACTITIONER WAS REMOVING THE INTRODUCER, IT BROKE OFF IN PRACTITIONER'S HAND. PARTS WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE PEEL-AWAY INTRODUCER (INSIDE PICC PACK) INTRODUCER DYB COOK MEDICAL INC. PICS-501-MPIS 3500803

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR