BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 2081165 · Received May 2, 2011

    Report

    Report Number
    2081165
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    February 22, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PLACED A QUICKSET CATHETER FOR HER MEDTRONIC INSULIN INFUSION PUMP IN HER LEFT UPPER BUTTOCK. WHEN SHE PULLED THE INTRODUCER NEEDLE BASE/HOLDER OUT, THE NEEDLE WAS NOT PRESENT AND THE HOLDER LOOKED SLIGHTLY JAGGED. BEFORE PLACEMENT, PATIENT REPORTED EVERYTHING LOOKED NORMAL. SHE THEN PULLED THE CATHETER OUT AND THE NEEDLE WAS NOT PRESENT EITHER. PATIENT PLACED ANOTHER CATHETER, PRESENTED FOR X-RAYS THE SAME DAY AND HAD SURGERY TO REMOVE THE NEEDLE UNDER FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET INTRAVASCULAR TUBING; INSULIN CATHETER FPA MEDTRONIC * 9201296

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR