BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL

    MDR report key: 9612827 · Received January 21, 2020

    Report

    Report Number
    9611594-2020-00010
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Report Date
    January 21, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    10680651132229
    PMA / PMN Number
    K131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA9154V01, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 21-JAN-2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2020-00011 FOR THE SECOND EVENT. REFER TO 9611594-2020-00012 FOR THE THIRD EVENT. REFER TO 9611594-2020-00013 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE DURING USE THE ENDOTRACHEAL LOSS TIDAL VOLUME WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION. THE PATIENT HAD TO UNDERGO REINTUBATION. THE DEVISE WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77065 MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13222 AA9154V01 10680651132229

    Patients

    Seq Age Sex Outcome Treatment
    1