BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/ SLOT

    MDR report key: 3003644 · Received February 12, 2013

    Report

    Report Number
    1317749-2013-00074
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2016. 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 STATED THAT THE DIALYSIS TUBE ADAPTER BROKE AT THE VENOUS-END OF THE CATHETER AFTER FINISHING DIALYSIS. THE CATHETER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61994 PALINDROME 23/40 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK