BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 45CM PERMCATH

    MDR report key: 3170835 · Received June 7, 2013

    Report

    Report Number
    1317749-2013-00174
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE PHYSICIAN STATES THE CATHETER WAS PLACED ON (B)(6) 2013. DURING A PROCEDURE ON (B)(6) 2013, IT WAS VERIFIED THAT THERE WAS LEAKAGE IN THE MIDDLE PORTION OF THE CATHETER ON THE ARTERIAL SIDE. ACCORDING TO THE PHYSICIAN, THE PERFORATION WAS NOT CAUSED BY THE PROCEDURE. THERE WAS NO INJURY REPORTED AND NO PERMANENT DAMAGE TO THE PT. THE EVENT DID NOT PROLONG THE PT'S HOSPITAL STAY AND THERE WAS NO BLEEDING IN EXCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253565 KIT 45CM PERMCATH PERITONEAL DIALYSIS CATHETER LFJ COVIDIEN 8831692001 205301X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK