BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7395788 · Received April 4, 2018

    Report

    Report Number
    2936999-2018-00222
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Report Date
    May 25, 2018
    Manufacturer
    MMJ SA DE CV(USD)
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (UDI). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS DEVICE IN THIS REPORT IS PRODUCT CODE: BSR, DEVICE CLASS: 1 REGULATION NUMBER: 868.5790 (510K EXEMPT). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE ANESTHESIOLOGIST FORWARDED AN EMAIL WHICH STATES HE BELIEVES THIS STYLET PART NUMBER 85864 IS "TOO SHORT AND FLIMSY".

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE ANESTHESIOLOGIST FORWARDED AN EMAIL WHICH STATES HE BELIEVES THIS STYLET PART NUMBER 85864 IS "TOO SHORT AND FLIMSY". IT WAS REPORTED THAT THIS PRODUCT IS "INFERIOR" DUE TO NOT PROVIDING ENOUGH SUPPORT AND THE OUTER COVERING BEING TOO SLICK. THERE WAS NO INJURY REPORTED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240673 MALLINCKRODT STYLET, TRACHEAL TUBE BSR MMJ SA DE CV(USD) 85864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other