BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES

    MDR report key: 19805610 · Received July 23, 2024

    Report

    Report Number
    8030647-2024-00061
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 23, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19 JUL 2024 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, UPON ATTACHING THE SUCTION TO THE VENTILATOR, THE VENT READ 100% LEAK, THERE WAS AUDIBLE AIR ESCAPING FROM THE PRODUCT AND THE PLASTIC TUBING WAS FILLED WITH AIR FROM THE VENT. IT WAS ADDITIONALLY REPORTED, ¿AIR CONTINUED TO ESCAPE WHETHER THE WHITE [BUTTON] WAS LOCKED OR UNLOCKED.¿ THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906380 UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown