BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CATHETER INSERTION KIT

    MDR report key: 6906659 · Received October 2, 2017

    Report

    Report Number
    6906659
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 28, 2017
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO INSERT A GUIDE WIRE ULTRASOUND IV, THE GUIDEWIRE WAS ADVANCED, BUT WOULD NOT GO ANY FURTHER. NURSE TRIED TO RETRACT, AND IT WOULD NOT COME BACK INTO CHAMBER. NURSE ATTEMPTED TO RETRACT NEEDLE WITH DIFFICULTY, BUT WAS MANAGED. NEEDLE WAS RETRACTED BUT GUIDE WIRE REMAINED IN PATIENTS ARM. NURSE WAS ABLE TO PULL GUIDE WIRE OUT WITH FORCE FROM PTS ARM. GUIDE WIRE APPEARED TO BE INTACT. PACKAGING SAVED BUT NEEDLE/CHAMBER/GUIDEWIRE WAS DISPOSED OF IN BIOHAZARD SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687919 PERIPHERAL CATHETER INSERTION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS OWL BARD ACCESS SYSTEMS, INC. AC0182250 REBV0326

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR