BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 3549758 · Received January 2, 2014

    Report

    Report Number
    3549758
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 24, 2013
    Report Date
    January 2, 2014
    Manufacturer
    VYGON CORP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE PREMICATH CATHETER TO ATTEMPT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACEMENT IN LEFT FOOT. WHILE SHE PLACED THE 24G SPLITTING NEEDLE IN, SHE ADVANCED PER GUIDELINES AND SNAPPED OFF WINGS PER USUAL PROCEDURE. HOWEVER AT THIS TIME, THE NEEDLE WAS UNABLE TO BE ADVANCED. THE ATTENDING PHYSICIAN WAS CALLED IN TO ASSIST WITH ADVANCEMENT AND AFTER ATTEMPTS, LINE WAS TAKEN OUT AND CATHETER NOTED TO BE BENT AT "WRONG PLACE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433 PREMICATH CATHETER MSD VYGON CORP 1261.203G 050313GB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY