BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED SWN NCK CRL CTH 42.9CM 2CM

    MDR report key: 1483676 · Received July 27, 2009

    Report

    Report Number
    1317749-2009-00171
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Date of Event
    February 1, 2009
    Report Date
    June 16, 2009
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2009, THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER ADAPTER. THE CUSTOMER REPORTS PATIENT'S ADAPTER FELL OUT OF THE PERITONEAL DIALYSIS CATHETER. IT WAS FURTHER REPORTED THAT THE PARENT OF THE PATIENT RE-CONNECTED THE ADAPTER TO THE CATHETER. PATIENT DEVELOPED PERITONITIS (B) (4) 2009, AND REQUIRED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PED SWN NCK CRL CTH 42.9CM 2CM PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 888413101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO