BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 23/40 SPRT W/VT

    MDR report key: 3842570 · Received February 24, 2014

    Report

    Report Number
    1317749-2014-00121
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT WHEN THE PT ARRIVED TO THE DIALYSIS CENTER FOR TREATMENT, A DIALYSIS NURSE NOTICED THAT A PIECE OF THE CATHETER'S ADAPTER WAS BROKEN OFF (WHERE THE DIALYSIS MACHINE CONNECTS TO). THIS RESTRICTED PT FROM FURTHER TREATMENT UNTIL REPAIRED. PT WAS THEN SENT TO THE DIALYSIS CENTER TO GET IT REPAIRED. THE ACCESS CENTER DOCTOR ENDED UP REPLACING THE CATHETER SINCE A FIBRIN ENDED UP REPLACING THE CATHETER SINCE A FIBRIN SHEATH HAD FORMED (NOT RELATING TO ADAPTER CRACKING/PIECE MISSING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112232 PALIND 23/40 SPRT W/VT DIALYSIS CATHETER MSD COVIDIEN 8888123404 224321X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK