BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PRESSURE INJECTABLE ARROWG+ARD BLUE PLUS THREE-LUMEN CVC

    MDR report key: 19894233 · Received August 1, 2024

    Report

    Report Number
    MW5157929
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 30, 2024
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PLACEMENT OF TRIPLE LUMEN CATHETER, THE WIRE SHEARED APART. THIS OCCURRED AFTER ACCESS HAD BEEN GAINED. THE WIRE REMAINING INSIDE THE PATIENT WAS INTACT UPON REMOVAL. HOWEVER, A SECOND ATTEMPT HAD TO BE MADE TO GAIN ACCESS AND PLACE THE TRIPLE LUMEN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384651 ARROW PRESSURE INJECTABLE ARROWG+ARD BLUE PLUS THREE-LUMEN CVC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ TELEFLEX LLC (NADC) CDC-45703-XPCN1A 33F23D0947

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male