BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    ARROW

    MDR report key: 16545594 · Received March 15, 2023

    Report

    Report Number
    16545594
    Event Type
    No answer provided
    Date Received
    March 15, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 27, 2023
    Manufacturer
    ARROW INTERNATIONAL, LLC
    Product Code
    MPB
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING UNCOMPLICATED QUINTON CATHETER PLACEMENT, IJ ACCESSED WITH NEEDLE WITHOUT DIFFICULTY. THEN NOTICED DIFFICULTY THREADING WIRE, SO ATTEMPTED TO RETRACT WIRE TO RETRY. AT THIS POINT WIRE WOULD NOT RETRACT FROM THE NEEDLE, ULTIMATELY LEADING TO NEEDING TO PULL OUT NEEDLE/WIRE TOGETHER, WITH RESISTANCE NOTED GETTING WIRE OUT OF SKIN. ONCE BOTH NEEDLE AND WIRE OUT OF SKIN, STILL UNABLE TO SEPARATE NEEDLE FROM WIRE - APPEARED THAT WIRE BECAME CAUGHT ON THE BEVEL OF THE NEEDLE AND BECAME STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037536 ARROW CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB ARROW INTERNATIONAL, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown