BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DY

    MDR report key: 1813074 · Received August 18, 2010

    Report

    Report Number
    1317749-2010-00214
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 3, 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

    (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 08/03/2010 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS THE PT DEVELOPED A HOLE ON (B)(6)2010 IN THE SILICONE TUBING AT THE BASE OF THE ADAPTER SITE. THE PT REQUIRED PROPHYLACTIC ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1