BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT STOPCOCK

    MDR report key: 1854092 · Received September 2, 2010

    Report

    Report Number
    2936999-2010-01151
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    FMG
    PMA / PMN Number
    K792126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNK, THEREFORE, UNABLE TO KNOW MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 08/19/2010 THAT A STOPCOCK HAD LEAKED/CRACKED WHERE THE TUBE CONNECTS TO THE STOPCOCK SEVERAL HOURS AFTER USE WHILE ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT STOPCOCK 1 WAY STOPCOCK FMG COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 ECMO