BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME 23/40 SPORT W/SLOT

    MDR report key: 3240229 · Received July 15, 2013

    Report

    Report Number
    1317749-2013-00233
    Event Type
    Other
    Date Received
    July 15, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 21, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    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 DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT DURING REMOVAL OF A TUNNELED CENTRAL VENOUS DIALYSIS CATHETER, THE CUFF REMAINED IN THE PATIENT POST LINE REMOVAL. THE CUFF REMAINED SOMEWHAT ADHERENT TO THE CATHETER (THEY COULD SEE THE FIBER REMNANTS AS FUZZ AROUND THE LINE AFTERWARDS). IT SEEMED THE BULK OF THE OUTER PART REMAINED WELL-FIBROSED TO SURROUNDING PATIENT TISSUES AND COULD NOT BE SEPARATED FROM THE PATIENT NON-SURGICALLY. IT WILL NEED TO BE SURGICALLY REMOVED (PROCEDURE STILL PENDING). THERE WAS NO PATIENT INJURY OR ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327757 PALINDROME 23/40 SPORT W/SLOT DIALYSIS CATHETER MSD COVIDIEN 8888123400 214527X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention