BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.8-8.0-28

    MDR report key: 10236418 · Received July 6, 2020

    Report

    Report Number
    3011270181-2020-00095
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 29, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038352169
    PMA / PMN Number
    K113333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN SECTION B3, DATE OF EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 28 JUL 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. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    USER FACILITY MDR (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06 JUL 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

    MDR USER FACILITY REPORT (B)(4) RECEIVED 12-JUN-2020 INDICATED "PATIENT ON VENT, VENT ALARMS SOUNDED. PT [PATIENT] NOTED TO HAVE 0 TV [TIDAL VOLUME] AND 0 MV [MINUTE VOLUME]. PT THEN BECAME BRADYCARDIC FOLLOWED BY ASYSTOLE. HR [HEART RATE] RETURNED AFTER ATROPINE. ETT [ENDOTRACHEAL TUBE] CUFF THEN NOTED TO HAVE A LARGE CUFF LEAK, AIR ADDED TO BALLOON AND ANESTHESIA PAGED TO CHANGE ETT. ONCE TUBE REMOVED BALLOON NOTED TO HAVE WATER IN IT." ADDITIONAL INFORMATION RECEIVED 24-JUN-2020 INDICATED THERE WAS "NO HARM TO PATIENT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699892 MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.8-8.0-28 VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35216 UNKNOWN 00609038352169

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention