BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DY

    MDR report key: 1833932 · Received September 2, 2010

    Report

    Report Number
    1317749-2010-00232
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    May 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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 ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT ON (B)(6) 2010 A PT NEEDED TO HAVE THE TUBING CHANGED DUE TO A HOLE THAT WAS NOTICED IN THE SILICONE, AT THE BASE OF THE ADAPTER. THE PT REQUIRED PROPHYLACTIC ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DY UNK DY FJS COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK