BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL-CATH CA2 RIGHT

    MDR report key: 2860261 · Received November 30, 2012

    Report

    Report Number
    1317749-2012-00304
    Event Type
    Other
    Date Received
    November 30, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THEIR PT PULLED THE CATHETER OUT LEAVING TWO CUFFS INSIDE THE PT. THE PT HAD TO BE SEDATED AND HAVE THE CUFFS SURGICALLY REMOVED AND A NEW CATHETER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK COIL-CATH CA2 RIGHT PERITONEAL DIALYSIS CATHETER FJS COVIDIEN 8888413815 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention