BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

    MDR report key: 15601950 · Received October 13, 2022

    Report

    Report Number
    15601950
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 21, 2022
    Report Date
    September 26, 2022
    Manufacturer
    VELANO VASCULAR
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I WAS STARTING AN IV AND HOOKED UP THE EXTENSION TUBING AND WAS UNABLE TO DRAW BACK BLOOD. I KNEW I HAD HIT THE VEIN SO I ATTEMPTED TO FLUSH THROUGH THE MAIN HUB AND NOT THROUGH THE TUBING. IT WORKED, BUT IT STILL WOULD NOT FLUSH BACK THROUGH THE TUBING EVEN THOUGH I DIDN'T LOCK IT. I GOT A NEW EXTENSION SET READY AND DISCONNECTED THE OLD SET AND PUT ON A NEW SET AND WAS ABLE TO DRAW BLOOD FROM THAT SET. I LATER FIGURED OUT THAT THE PLACE WHERE YOU HOOK UP THE CLAVE WHERE IT CONNECTS TO THE TUBING THERE WAS A FILM OF THE RUBBER OR PLASTIC COVERING THE TUBING THAT WAS PREVENTING IT FROM FLUSHING OR DRAWING BACK BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272061 TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA VELANO VASCULAR 201-0016 9451604

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Male