BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD IV CATHETER

    MDR report key: 637285 · Received August 10, 2005

    Report

    Report Number
    MW4004030
    Event Type
    Injury
    Date Received
    August 10, 2005
    Date of Event
    May 26, 2005
    Report Date
    July 7, 2005
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT IN FOR INFUSION OF IVIG. PT HAS PORT, ALTHOUGH UNABLE TO RE-ACCESS PORT AFTER PATIENT COMPLAINT OF PAIN AND BURNING DURING IVIG INFUSION. PER IV RN, 2 PIV (22G) STARTED TO LEFT HAND AT APPROX 0050. IVIG INFUSION RESTARTED INTO 1 OF PIV'S. APPROX 0300, PIV WITH IVIG INFUSION NOITED TO BE BLEEDING FROM SITE AND WHEN TAPE TAKEN DOWN, CATHETER KINKED AND WITH SMALL TEAR IN PLASTIC CATHETER , CATHETER REMOVED FROM PATIENT INTACT. IVIG INFUSION SWITCHED TO OTHER PIV AND AT APPROX 0345, PIV NOTED TO BE BLEEDING FROM SITE AS WELL. ONCE AGAIN CATHETER NOTED TO BE KINKED AND WITH SMALL TEAR IN PLASTIC CATHETER, CATHETER REMOVED FROM PATIENT INTACT (SAVED IN BIOHAZARD BAG). NURSE STARTED A NEW 24G IN LEFT WRIST AND 22G IN RIGHT HAND. IVIG INFUSION RESUMED IN LEFT WRIST PIV. AT APPROX 0540, PATIENT CALLED RN INTO ROOM AND RN NOTED THAT RIGHT HAND PIV WITH LARGE AMOUNT OF BLEEDING FROM THE SITE. WHEN TAPE PULLED BACK, CATHETER NOTED TO BE COMPLETELY BROKEN AND BROKEN PIECE REMAINED IN PATIENT'S HAND WHILE THE REST OF PIV REMAINED IN PATIENT'S HAND WHILE THE REST OF PIV REMAINED STUCK TO TAPE. RN PULLED BROKEN CATHETER OUT OF PATIENT'S HAND COMPLETELY AND PLACED IN BIOHARZARD BAG. SHORTLY AFTER AT APPROX 0545, PIV IN LEFT WRIST BEEPING OCCLUDED. WHEN TAPE PULLED DOWN, CATHETER NOTED TO BE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD IV CATHETER IV CATHETER FOZ BECTON DICKINSON & CO. 381523 *
    2 BD INSYTE AUTOGUARD IV CATHETER IV CATHETER FOZ BECTON, DICKINSON & CO. 381512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention