BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTROSYTE-N, BD INSTAFLASH

    MDR report key: 12364778 · Received August 25, 2021

    Report

    Report Number
    12364778
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 29, 2021
    Report Date
    July 30, 2021
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEONATAL NURSE PRACTITIONER (NNP) PLACED A PICC LINE INTO PATIENT USING INTROSYTE-N INTRODUCER. AFTER VEIN WAS ACCESSED, THE NEEDLE WAS MOVED AND PICC CATHETER ADVANCED WITHOUT DIFFICULTY. NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED. SO THERE WAS NO WAY TO CONTINUE TO REMOVE THE PEEL AWAY CATHETER. NNP HAD TO HAVE ANOTHER NNP SCRUB IN TO HOLD PICC CATHETER IN PLACE WHILE TWEEZERS WERE USED TO SLOWLY PICK OFF THE REST OF THE PEEL AWAY CATHETER. THIS WAS SUCCESSFUL AND NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261855 BD INTROSYTE-N, BD INSTAFLASH CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ 384021 1005635

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA