BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE

    MDR report key: 16506399 · Received March 8, 2023

    Report

    Report Number
    8030647-2023-00042
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 2, 2023
    Report Date
    May 17, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038989655
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30105098 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE ENTIRE DEVICE WAS VISUALLY INSPECTED FOR DAMAGE, NO BREAKAGES OR DAMAGES WERE SEEN AT THE OUTER PORTION OF THE DEVICE. THE POSITION OF THE THUMB VALVE WAS IN THE UPRIGHT POSITION WHEN RECEIVED. THE THUMB VALVE WAS PRESSED AND RELEASED MULTIPLE TIMES FOR FUNCTIONAL INSPECTION. EACH TIME AFTER RELEASE, THE THUMB VALVE RETURNED TO THE UPRIGHT POSITION. THE THUMB VALVE WAS ALSO INSPECTED IF THE ROTATION WAS POSSIBLE, MULTIPLE TIMES (3 TIMES), THE THUMB VALVE WAS ROTATED FROM THE UNLOCKED TO LOCKED POSITION, AND THERE WERE NO DIFFICULTIES OR ISSUES SEEN. THE SAMPLES WERE ALSO MEASURED FOR DIMENSIONS ON THE CONTROL VALVE BODY (CVB) AND SEAL COMPONENTS. AN INTERFERENCE WAS OBSERVED BETWEEN THE SEAL AND CVB. THE INCIDENT WAS CONFIRMED AS REPORTED. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17 MAY 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 07 MAR 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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 (B)(4), 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, THE LOCKING SYSTEM ON THE THUMB VALVE GOT STUCK (DOWN) IN THE SUCTION MODE AND THE BUTTON HAD TO BE PULLED OUT MANUALLY. IT WOULDN'T SPRING OUT AS IT SHOULD WHEN LOCKING. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735735 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 227-5 30105098 00609038989655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown