BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/SLOT

    MDR report key: 3190227 · Received June 10, 2013

    Report

    Report Number
    1317749-2013-00181
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT A PATIENT RECENTLY HAD AN INCIDENT WITH HIS PALINDROME CATHETER AND HAD TO HAVE IT REMOVED. THE PATIENT HAD A PALINDROME CATHETER INSERTED ON THE (B)(6) 2011 IN RIGHT JUGULAR. WHEN STARTING DIALYSIS ON THE (B)(6) 2013 THE NURSE DISCOVERED SMALL AIR BUBBLES IN DIALYSIS TUBING FROM THE ARTERIAL SIDE. WHEN REMOVING THE CATHETER A DEFECT WAS FOUND ON THE WHITE Y-PART (BETWEEN THE CATHETER SHAFT AND THE EXTENSIONS), THERE WAS AN AIR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261918 PALINDROME 23/40 KIT W/SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145015 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN