BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG

    MDR report key: 19497494 · Received June 10, 2024

    Report

    Report Number
    19497494
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    April 8, 2024
    Report Date
    April 16, 2024
    Manufacturer
    TELEFLEX, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PLACING PICC ON PATIENT. VENOUS ACCESS WAS ACHIEVED ON LEFT ARM. GUIDE WIRE WAS THREAD INTO NEEDLE. RESISTANCE WAS MET AFTER A A FEW CM OF ADVANCEMENT. THERE WAS RESISTANCE FELT WHEN TRYING TO RETRACT THE GUIDE WIRE. I GAVE LET GO OF THE WIRE TO LET THE VEIN RELEASE THE POSSIBLE SPASM OCCURRING. A COUPLE MINUTES LATER I AGAIN STARTED TO RETRACT THE WIRE. UPON RETRACTION THE WIRE STARTED TO UNRAVEL AND GET THIN, BUT WAS NOT COMING OUT OF THE ARM. I STOPPED ANY FURTHER ATTEMPT TO REMOVE THE WIRE AND PATIENT WAS SENT TO IR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205289 ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS TELEFLEX, INC. IPN924168 33F23G0488

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown