BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/ SLOT

    MDR report key: 3843541 · Received February 11, 2014

    Report

    Report Number
    1317749-2014-00079
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014 THAT CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER CUFF CAME OFF DURING HEMODIALYSIS TREATMENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91062 PALINDROME 23/40 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145015 114021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK