BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3942104 · Received March 4, 2014

    Report

    Report Number
    2936999-2014-00203
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS RECEIVED A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING PRE-TEST, A NURSE NOTICED THE BALLOON IN THE BRONCO-CATH CUFF DID NOT DEFLATE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129629 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201303259X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown