BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYS NEO/PEDS,5FR

    MDR report key: 16556333 · Received March 16, 2023

    Report

    Report Number
    8030647-2023-00058
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Report Date
    April 14, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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, 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, 30188809, 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 RECEIVED. 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 (THREE 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 WITH THE SUCTION SET AT 120MMHG. UPON CONNECTION, WHILE STILL ENGAGED WITH THE SUCTION SYSTEM, 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 DISTAL END OF THE CATHETER WAS INSPECTED FOR BLOCKED SKIVE. THE SKIVES WERE VISIBLE, THERE WAS NO BLOCKAGE AT THE TIP OF THE CATHETER. THE CATHETER BODY WAS FULLY EXTENDED AND EXAMINED. THERE WERE NO SIGNS OF DAMAGED/ PINCHED/ CURVED TUBING. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 13-APR-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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CLOSED SUCTION CATHETER "COULD NOT SUCTION. AFTER REPLACING THE CATHETER FOR NEW ONE, THERE WAS NO PROBLEM." THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844304 BALLARD CLOSED SUCTION SYS NEO/PEDS,5FR VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 195-4J 30188809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown