BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT A CATH II

    MDR report key: 1931309 · Received December 13, 2010

    Report

    Report Number
    MW5018586
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    UNK
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH WAS PLACED (B)(6) 2009. STARTED HAVING PROBLEMS WITH INFUSION. X-RAY WITH CONTRAST DONE ON (B)(6) 2010 REVEALING: FINDINGS - THERE HAS BEEN APPROXIMATELY 3 CM OF RETRACTION OF THE TIP OF THE CATHETER. CONTRAST TRACKS ALONG THE OUTSIDE OF THE CATHETER CONSISTENT WITH A FIBRIN SHEATH. EXTRAVASATION OF CONTRAST AND A FIBRIN SHEATH. EXTRAVASATION OF THE CONTRAST DYE IS NOTED IN THE NECK REGION. FINDINGS LIKELY REPRESENT A FRACTURE OF THE CATHETER AND A FIBRIN SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT A CATH II PORT A CATH LJT UNK REFERENCE NUMBER- 1656521

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization