BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGUARD BLUE

    MDR report key: 3831937 · Received May 21, 2014

    Report

    Report Number
    3831937
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    TELEFLEX INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE CATHETER USED TO MEASURE PULMONARY ARTERY PRESSURE HAD A HOLE ON THE SIDE, CAUSING BLOOD TO DRIP OUT. DISCOVERED AFTER LINE WAS INSERTED. A NEW CATHETER WAS OPENED AND USED.====================== MANUFACTURER RESPONSE FOR 8.5 FRENCH SWAN CATHETER, 10CM SHEATH, TELEFLEX (PER SITE REPORTER).====================== THEY WANT US TO SEND THE FAILED CATHETER BACK AND THEY WILL SEND US A REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302484 ARROWGUARD BLUE CADIOVASCULAR CATHETER SHEATH INTRODUCER KIT DQO TELEFLEX INC. SF-29803-1 23F14B1020

    Patients

    Seq Age Sex Outcome Treatment
    1 *