BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS TRAY WITH CATHETER

    MDR report key: 3121871 · Received May 15, 2013

    Report

    Report Number
    MW5030219
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, DR (B)(6) WAS PERFORMING A THORACENTESIS WITH A CAREFUSION THORACENTESIS TRAY WITH CATHETER. AFTER INSERTING THE THORACENTESIS NEEDLE/CATHETER, HE WAS UNABLE TO PULL OUT OR PUSH IN FLUID. THE CATHETER WAS REMOVED AND FOUND TO BE NON-PATENT, EVEN THOUGH IT WAS BRAND NEW. A SECOND TRAY WAS OBTAINED AND THE PROCEDURE WAS REPEATED. THE DEFECTIVE NEEDLE/CATHETER HAS BEEN PLACED IN THE DIRTY ROOM FOR RISK MANAGEMENT. FOLLOWING THIS EVENT THE PULMONOLOGIST SAID THAT THIS HAS OCCURRED BEFORE, THAT THIS WASN'T THE FIRST TIME HE'S HAD A DEFECTIVE CATHETER WITH THE CAREFUSION THORACENTESIS TRAY. DATES OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215074 THORACENTESIS TRAY WITH CATHETER THORACENTESIS TRAY WITH CATHETER LRO CAREFUSION 0000534616

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other