BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE, WET PAK

    MDR report key: 7772552 · Received August 10, 2018

    Report

    Report Number
    8030647-2018-00500
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 3, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO DAMAGES OR ABNORMALITIES. THE FLAPPER VALVE WAS EXAMINED AND FOUND TO REMAIN CLOSED WHEN THE CATHETER IS NOT ADVANCED. AN ATTEMPT TO DUPLICATE THE REPORTED LEAK BY USING WATER WAS PERFORMED. NO LEAK WAS OBSERVED. THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. NO ROOT CAUSE IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 10 OCT 2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT M6242T802 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 08 AUG 2018 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK AT THE JUNCTION BETWEEN THE SHEATH AROUND THE TUBING AND ON THE BLUE VALVE SIDE. THE SUCTION WAS NOT EFFECTIVE. THE SYSTEM WAS CHANGED OUT FOR A NEW DEVICE. NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615258 MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE, WET PAK VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 240146-5 M6242T802

    Patients

    Seq Age Sex Outcome Treatment
    1