BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC QUICK SET 6MM

    MDR report key: 2016320 · Received March 4, 2011

    Report

    Report Number
    MW5019707
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 4, 2011
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHRISTINA CALLED TO SAY SHE PLACED A MEDTRONIC QUICKSET CATHETER FOR HER MEDTRONIC INSULIN INFUSION PUMP IN LEFT UPPER BUTTOCKS ON (B)(6) 2011. WHEN SHE PULLED THE INTRODUCER NEEDLE BASE/HOLDER OUT, THE NEEDLE WAS NOT PRESENT & THE HOLDER LOOKED SLIGHTLY JAGGED. BEFORE PLACEMENT, SHE NOTED ALL LOOKED NORMAL. SHE THEN PULLED THE CATHETER OUT & THE INTRODUCER NEEDLE WAS NOT IN IT EITHER. SHE IS UNCOMFORTABLE AND SUSPECTS NEEDLE REMAINS IN HER SUBCUTANEOUS FAT. SHE CAME IN, BROUGHT HER SUPPLIES, LOT NUMBER 9201296. SHE WAS SENT TO SDC FOR X-RAY AND FOLLOWUP. WE ALERTED MEDTRONIC. UNABLE TO EXTRACT NEEDLE IN SDC & PT STILL IS BOTHERED. SHE IS SCHEDULED FOR SURGICAL REMOVAL ON (B)(6) 2011. MEDTRONIC STATED THEY WOULD BE SENDING HER A CARTON FOR HER TO RETURN PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK SET 6MM INSULIN PUMP CANNULA FPA 9201296

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Disability