BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2903842 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00728
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN FORMERLY TYCOHEALTHCARE
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED, A SUMMARY OF THE INVESTIGATION REPORT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING INSPECTION PRIOR TO USE ON A PT AT HOSPITAL, A NURSE CONFIRMED THE AIR COULD NOT BE DEFLATED COMPLETELY ONLY. CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN FORMERLY TYCOHEALTHCARE 201204338X

    Patients

    Seq Age Sex Outcome Treatment
    1