BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC

    MDR report key: 9170055 · Received October 8, 2019

    Report

    Report Number
    8030647-2019-00094
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 14, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE THUMB VALVE WAS RECEIVED IN THE DOWN POSITION. THE VALVE COULD MANUALLY BE PULLED UP, HOWEVER, WHEN DEPRESSED AND RELEASED, THE THUMB VALVE REMAINED IN THE DOWN POSITION. THE COMPLAINT WAS CONFIRMED AS REPORTED. ROOT CAUSE TRACED TO MANUFACTURING. ALL INFORMATION REASONABLY KNOWN AS OF 13 NOV 2019 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 · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT M19091T502 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 08 OCT 2019 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THUMB VALVE WAS STUCK DOWN DURING SUCTIONING. THE HEALTHCARE PROFESSIONAL STOPPED THE SUCTIONING ONCE THE STUCK VALVE WAS NOTICED. THE SUCTION CATHETER WAS REPLACED WITH A NEW ONE AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961741 BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 196-4J M19091T502

    Patients

    Seq Age Sex Outcome Treatment
    1