BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 1781364 · Received July 29, 2010

    Report

    Report Number
    1317749-2010-00205
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    December 10, 2009
    Report Date
    July 9, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN TISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS THE SILICONE EXTENSION DEVELOPED A HOLE AT THE END OF THE ADAPTER. ADAPTER EXCHANGE DONE ON (B)(6) 2009. THE PATIENT REQUIRED PROPHYLACTIC ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK COIL CATH CA2 LEFT PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888413807 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR