BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 6 F, Y-ADAPTER

    MDR report key: 10967948 · Received December 8, 2020

    Report

    Report Number
    8030647-2020-00102
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 14, 2020
    Report Date
    February 3, 2021
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30032364 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING. THE REPORTED EVENT WAS CONFIRMED. ROOT CAUSE WAS IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2021 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 · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2020 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).

    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 IT WAS NOTICED THE THUMB VALVE WAS STUCK. THE SUCTION CATHETER WAS REPLACED FOR NEW ONE IMMEDIATELY. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434198 BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 6 F, Y-ADAPTER VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 196-4J 30032364

    Patients

    Seq Age Sex Outcome Treatment
    1