BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED ENDOTRACH TUBE

    MDR report key: 13498586 · Received February 9, 2022

    Report

    Report Number
    2936999-2022-00093
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    May 8, 2021
    Report Date
    February 9, 2022
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: DIFFICULT TRACHEAL EXTUBATION DUE TO ENDOTRACHEAL TUBE MALFUNCTION: A CHALLENGE DURING THE COVID-19 PANDEMIC SOURCE: JOURNAL OF TAIBAH UNIVERSITY MEDICAL SCIENCES VOLUME 16, ISSUE 6, DECEMBER 2021, PAGES 935-937. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 3RD OF FEBRUARY TO 8TH OF MAY 2021, THE DEVICE HAD FAILED CUFF DEFLATION AND DAMAGED PILOT TUBE. MAGILL FORCEPS WERE USED TO BREAK AND DEFLATE THE CUFF TO ALLOW FOR EXTUBATION. THIS WAS ASSOCIATED WITH THE ADULT MALE AND HAD URGENT LAPAROSCOPIC CHOLECYSTECTOMY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836733 UNSPECIFIED ENDOTRACH TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV (USD) UNSPECIFIED ENDOTRACH TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male