BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN NECK MISSOURI SN M2 RGHT

    MDR report key: 2913883 · Received December 6, 2012

    Report

    Report Number
    1317749-2012-00310
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    August 25, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SUBMIT DATE: (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE REPORTER STATED THAT LEAKAGE OF PERITONEAL LIQUID WAS OBSERVED ON THE PT'S (MALE, (B)(6)) ABDOMEN, COMING FROM THE PD CATHETER. THE CATHETER HAD BEEN IN PLACE SINCE (B)(6) 2010. DURING THE REMOVAL OF THE CATHETER, A CUT IN THE CATHETER WAS OBSERVED. PRESENCE OF STAPHYLOCOCCUS EPIDERMIDIS METI-R AND ENTEROCOCCUS FAECALIS WAS NOTED. THE PT WAS TREATED WITH BOTH ORAL AND INJECTABLE ANTIBIOTHERAPY. THE PERITONEUM STAYED AT REST. ON (B)(6) 2012, A CENTRAL VENOUS CATHETER WAS PLACED UNDER LOCAL ANESTHESIA. HE WAS HEMODIALYZED FOR TWO MONTHS. ON (B)(6) 2012, A PD CATHETER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK MISSOURI SN M2 RGHT DIALYSIS CATHETER MPB COVIDIEN 8888412619 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening