BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7502960 · Received May 10, 2018

    Report

    Report Number
    2936999-2018-00335
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 10, 2018
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTR
    UDI-DI
    30884522000134
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    K871204. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE HAD BROKEN PILOT BALLOON. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346613 MALLINCKRODT TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV (USD) 86113 17G0691JZX 30884522000134

    Patients

    Seq Age Sex Outcome Treatment
    1