BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW

    MDR report key: 17121782 · Received June 13, 2023

    Report

    Report Number
    8030647-2023-00089
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Report Date
    October 16, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038939056
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G4. THE DEVICE HISTORY RECORD FOR LOT 30240008 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE REVEALED THE SLEEVE WAS FREE OF TEARING AND/OR DAMAGE AND THE MANIFOLD WAS FREE OF CRACKS AND/OR ANY DEFORMATION(S). IT WAS ADDITIONALLY NOTED, THE CONTROL VALVE FUNCTIONED AS INTENDED, AND THE MALE AND FEMALE SWIVEL APPEARED INTACT AND SWIVELED ACCORDINGLY. TESTING OF THE SAMPLE: A CTS LEAK TEST SYSTEM WAS USED TO CREATE AIR INFLATION; THE MANIFOLD TEST ADAPTOR WAS ATTACHED TO THE CTS TEST PORT, THE MALE SWIVEL WAS ATTACHED TO THE 15MM MALE TEST ADAPTOR AND THE FEMALE PLUG WAS ATTACHED TO THE FEMALE SWIVEL. DURING TESTING, WHEN THE CATHETER TIP WITH SKIVES WAS IN THE CORRECT POSITION (OUTSIDE OF THE PEEP SEAL AREA), NO AIR LEAK (SOUND) WAS EXPERIENCED AND NO SLEEVE INFLATION WAS OBSERVED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS REPORTED; THEREFORE, THE ROOT CAUSE IS UNDETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09 OCT 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 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.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12 JUN 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 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    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 07 JUL 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 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE FIRST OF SEVEN REPORTS. REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214134 BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 2160 30240008 00609038939056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown