BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SUCTION SYSTEM FOR ADULTS, 12 F DSE

    MDR report key: 15126221 · Received July 28, 2022

    Report

    Report Number
    8030647-2022-00169
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Report Date
    November 23, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038982984
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 28-JUL-2022 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). 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

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30143005, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE SAMPLE WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. NO OTHER COMPONENTS WERE RETURNED. THE FLEX CONNECTOR WAS RECEIVED ATTACHED INTO THE FEMALE SWIVEL. THE ENTIRE DEVICE WAS VISUALLY INSPECTED FOR DAMAGE, NO BREAKAGES OR DAMAGES SEEN. THE POSITION OF THE THUMB VALVE WAS IN THE UPRIGHT POSITION. 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 SAMPLE WAS THEN ATTACHED TO THE SUCTIONING EQUIPMENT. UPON CONNECTION, WHILE STILL ENGAGED WITH THE SUCTION EQUIPMENT, THE DISTAL END OF THE CATHETER WAS INSERTED IN A BEAKER OF WATER WITH BLUE DYE. THE SUCTIONING DID NOT OCCUR WHEN THE THUMB VALVE WAS PRESSED. THE THUMB VALVE WAS TURNED INTO LOCKED POSITION. THE SUCTIONING DID NOT OCCUR AS WELL WHEN THE VALVE WAS PLACED IN THE LOCKED POSITION. THE ROOT CAUSE WAS MANUFACTURING RELATED. ALL INFORMATION REASONABLY KNOWN AS OF 22-NOV-2022 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 (B)(6), 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 WHEN THE THUMB VALVE WAS PUSHED, IT DID NOT SUCTION. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117656 CLOSED SUCTION SYSTEM FOR ADULTS, 12 F DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 21603-5 30143005 00609038982984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown