BEUDAMED
    FDA Adverse Event Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 1883960 · Received September 28, 2010

    Report

    Report Number
    1883960
    Date Received
    September 28, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PT IS A PEDIATRIC PT. WHEN RN WENT IN PT'S ROOM TO CHECK ON PATIENT'S PERIPHERAL IV, IT WAS FOUND TO NO LONGER BE IN PT'S VEIN AND THE END OF THE CATHETER WAS BROKEN. A SMALL PIECE OF THE CATHETER WAS FOUND IN THE PT'S BED AND ANOTHER SMALL PIECE OF THE CATHETER WAS FOUND ON THE FLOOR OF THE PT'S ROOM. THE BEVELED TIP OF THE CATHETER WAS FOUND AND ALL PIECES OF THE CATHETER WERE LOCATED. THE CATHETER HAD BEEN PLACED IN THE ANTECUBITAL AND THE PT WAS VERY ACTIVE. ANOTHER PERIPHERAL IV WAS STARTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PER THE PEDIATRIC UNIT MANAGER, "IT IS A MYSTERY HOW THE CATHETER WOULD HAVE BEEN SEVERED AT THE HUB AND THEN AGAIN IN THE MIDDLE OF THE CANNULA. WITH CONFIDENCE WE FEEL WE RETRIEVED THE ENTIRE AMOUNT OF PLASTIC CATHETER, SO WE DID NOT FEEL THE NEED FOR ANY INTERVENTION TO THE PT (INTERVENTIONAL RADIOLOGY). IT WAS A 24 GAUGE 0.56 INCH CATHETER AND THE TWO PIECES MATCHED IN LENGTH TO A NEW CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE-N AUTOGUARD CATHETER, IV FOZ BD MEDICAL * 0092137

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR