BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH BREAK-AWAY NEEDLE

    MDR report key: 1073987 · Received July 3, 2008

    Report

    Report Number
    2925153-2008-00004
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 22, 2008
    Report Date
    July 7, 2008
    Manufacturer
    NEOMEDICAL, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARE IS REQUIRED WHEN USING THE BREAK-AWAY NEEDLE. THE PRODUCT IFU GIVES CLEAR DIRECTIONS CONCERNING THE USE OF THE NEEDLE. IT STATES "CAUTION, NEVER PULL THE CATHETER BACK WHILE THE NEEDLE IS IN THE VEIN. THIS ACTION COULD DAMAGE OR SHEAR THE CATHETER." THE USER APPARENTLY DID NOT FOLLOW THE IFU INSTRUCTIONS. THE PRODUCT SAMPLE WILL HAVE TO BE STERILIZED PRIOR TO EXAMINATION. THE PT IS STABLE.

    Description of Event or Problem · 1

    BASED ON THE REPORT, RECEIVED AT NEOMEDICAL IN 2008, WHILE A BD CATHETER WAS BEING THREADED THROUGH A 2 FR BREAK-AWAY NEEDLE, RE-ORDER LOT # 1122, DIFFICULTY WAS EXPERIENCED. THE USER WITHDREW THE CATHETER AT THAT POINT, CAUSING IT TO BE SHEARED WHILE IT WAS STILL IN THE PT. ADD'L THE STATES THAT 7 CM OF CATHETER REMAINED IN THE VEIN AND SURGICAL INTERVENTION WAS NEEDED. THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH BREAK-AWAY NEEDLE V- CATH INTRODUCER DYB NEOMEDICAL, INC. 350-20 1122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention