BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC CONN TBE 5MMX3.7M BULK

    MDR report key: 6328818 · Received February 14, 2017

    Report

    Report Number
    9612030-2017-00065
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Report Date
    January 19, 2017
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 2/14/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 1/19/2017 THAT A CUSTOMER HAD AN ISSUE WITH A SUCTION TUBE. THE CUSTOMER REPORTS SUCTION IN THEIR ORTHO PACKS HAS A BLUE END, IS VERY PLIABLE/RIGID RESULTING IN COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110740 NC CONN TBE 5MMX3.7M BULK SUCTION TUBING JOL COVIDIEN 5558301536

    Patients

    Seq Age Sex Outcome Treatment
    1