BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY 40CM PERMCATH

    MDR report key: 800530 · Received December 22, 2006

    Report

    Report Number
    1317749-2006-00243
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    January 1, 2006
    Report Date
    November 28, 2006
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    LFJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYCO HEALTHCARE/KENDALL CONTINUES TO PURSUE THE RETURN OF THE DEVICE FOR EVALUATION. VOICEMAILS HAVE BEEN LEFT ON 11/29/2006, 12/05/2006, 12/13/2006, AND 12/22/2006 FOR RPTR BUT THEY HAVE NOT BEEN RETURNED. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON ITS COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON NOVEMBER 28, 2006, THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATES UPON REMOVAL OF THE PERMACATH, A PIECE OF THE CATHETER TIP SEPARATED AND REMAINED IN THE PATIENT. THE PHYSICIAN REMOVED THE TIP OF THE CATHETER UNDER FLUOROSCOPY X-RAY. NO RESIDUAL WAS SEEN ON X-RAY PER PHYSICIAN. THE CATHETER HAD BEEN IMPLANTED FOR APPROXIMATELY THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY 40CM PERMCATH DIALYSIS CATHETER LFJ TYCO HEALTHCARE/KENDALL 8817681001 536046

    Patients

    Seq Age Sex Outcome Treatment
    1 YR