BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 6902868 · Received September 28, 2017

    Report

    Report Number
    8020889-2017-05143
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 14, 2017
    Report Date
    January 8, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    UDI-DI
    40884522008748
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CORRECTION REPORT IS TO CLARIFY THAT REGULATORY REPORT # 8020889-2017-05143 IS NO LONGER APPLICABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A COMMUNICATION THAT ANESTHETIST INTUBATED AND INSERTED TUBE INTO PATIENT'S AIRWAY, WENT TO RETRACT BOUGIE AND FELT RESISTANCE, UPON CHECKING THE PART OF THE TUBE THAT JOINS HAD SHAVED LITTLE BITS OFF OF THE BOUGIE AND THESE BLUE SHAVINGS COULD BE SEEN INSIDE THE TUBE. THE CUSTOMER REPORTED THAT HE PRODUCT WAS TESTED PRIOR TO USE AND IT WAS UNKNOWN IF THE PRODUCT WAS TREATED WITH DISINFECTANT/CLEANING SOLUTIONS. THEY REPORTED THAT A PATIENT WAS INVOLVED, BUT NO INJURY HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682295 SHILEY TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 125037 201308065X 40884522008748

    Patients

    Seq Age Sex Outcome Treatment
    1