BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-C CONN TUBE 6MMX3.7M

    MDR report key: 6328856 · Received February 14, 2017

    Report

    Report Number
    9612030-2017-00066
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Report Date
    January 19, 2017
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/14/2017. 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 (B)(6) 2017 THAT A CUSTOMER HAD AND 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
    113270 N-C CONN TUBE 6MMX3.7M SUCTION TUBING BTR COVIDIEN 5558301627

    Patients

    Seq Age Sex Outcome Treatment
    1