BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 3193498 · Received June 20, 2013

    Report

    Report Number
    MW5030672
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    November 22, 2011
    Report Date
    June 20, 2013
    Manufacturer
    BARD MEDICAL DEVICE
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH IDIOPATHIC THROMBOCYTOPENIC PURPURA HAD A PORT-A-CATH PLACED INITIALLY ON (B)(6) 2010. WHEN ATTEMPTED TO USE IN (B)(6) 2011, PORT NOT FUNCTIONING AND X-RAYS SHOWED LEAKAGE OF THE CATHETER JUST PROXIMAL TO WHERE IT ENTERED THE SUBCLAVIAN VEIN. ON REMOVAL OF CATHETER, IT WAS NOTED TO HAVE A COMPLETE TRANSECTION OF THE DISTAL PORTION OF THE CATHETER AT APPROXIMATELY 9 CM. UNABLE TO SEE FRAGMENT ON INTRA OPERATIVE FLUORO OR CXR. POST OP CT WITH CONTRAST COMPLETED WHICH CONFIRMED LOCATION OF DISTAL PORTION OF CATHETER. SUBSEQUENTLY RETAINED CATHETER FRAGMENT EXTENDING FROM LEFT INNOMINATE VEIN INTO RIGHT INNOMINATE VEIN SUCCESSFULLY REMOVED BY INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281478 BARD PORT-A-CATH LJT BARD MEDICAL DEVICE 0604520

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention