BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DY

    MDR report key: 2166632 · Received July 6, 2011

    Report

    Report Number
    1317749-2011-00203
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    February 25, 2008
    Report Date
    June 29, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS PATIENT HD HAD A SWAN NECK CURL CATHETER INSERTED ON (B)(6) 2006. A HOLE WAS DISCOVERED IN THE CATHETER JUST BELOW THE ADAPTER ON (B)(6) 2008. THE PT WAS GIVEN ANTIBIOTICS AND THE TUBING WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DY PERITONEAL DIALYSIS CATHETER FJS COVIDIEN UNKNOWN DY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN