BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN NECK COIL CATH CA2 LEFT

    MDR report key: 3204235 · Received June 26, 2013

    Report

    Report Number
    1317749-2013-00191
    Event Type
    Other
    Date Received
    June 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 28, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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 DIALYSIS CATHETER. THE CUSTOMER STATES, THE PD CATHETER PLACED ON (B)(6) 2010, POSITIONED IN THE LEFT LOWER QUADRANT. ON (B)(6) 2013, A HOME PATIENT NOTIFIED STAFF AT DAVITA DIALYSIS THAT CATHETER WAS LEAKING BECAUSE OF A HOLE IN THE CATHETER. A STAFF MEMBER OBSERVED A HOLE IN CATHETER. A STAFF MEMBER OBSERVED A HOLE IN CATHETER AT THE POINT WHERE THE BETA CAP ADAPTER COMES INTO CONTACT WITH THE INNER PART OF THE PD CATHETER. THE CATHETER WAS REPAIRED ON (B)(4) 2013 BY DAVITA STAFF MEMBER. THE PATIENT WAS SENT FOR LAB TESTING AND AS A PRECAUTION WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS IN CASE OF PERITONITIS. LABS RESULTS CONFIRMED THAT THE PATIENT DID HAVE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289659 SWAN NECK COIL CATH CA2 LEFT DIALYSIS CATHETER FJS COVIDIEN 8888413807 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention