BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 5 F, Y-ADAPTER

    MDR report key: 11372561 · Received February 24, 2021

    Report

    Report Number
    8030647-2021-00005
    Event Type
    Injury
    Date Received
    February 24, 2021
    Report Date
    April 2, 2021
    Product Code
    BSY
    UDI-DI
    00609038983837
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED ON COMMUNICATION WITH THE USER FACILITY, THE ROOT CAUSE FOR THIS ISSUE IS NOT RELATED TO THE CLOSED SUCTION CATHETER. ALL INFORMATION REASONABLY KNOWN AS OF 01 APR 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 21 CFR 803, 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 DEVICE HISTORY RECORD FOR LOT 30058035 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 23 FEB 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLEAR PLASTIC SHEATH OF THE SUCTION CATHETER WAS INFLATED. THE PATIENT HAD JUST HAD INLINE SUCTION PERFORMED. THE VENTILATOR BEGAN ALARMING AND SWITCHED TO BACKUP MODE; THE APNEA ALARM WAS ALSO SHOWING. NO CHEST MOVEMENT WAS SEEN. PATIENT WAS CLINICALLY STABLE ON MANUAL VENTILATION VIA NEOPUFF. USER FACILITY REPORTED "CONTINUED MANUAL VENTILATION IN BETWEEN TRIALS OF GETTING BACK ONTO THE VENTILATOR, [PATIENT] REMAINED WELL." ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY ON 04-FEB-2021 INDICATED "AFTER FURTHER INVESTIGATION BY OUR UNIT, IT WAS DISCOVERED THAT THIS PROBLEM WAS NOT A MANUFACTURING FAULT AND FURTHER TRAINING WILL BE GIVEN TO STAFF. THANK YOU FOR YOUR HELP WITH THIS AND APOLOGIZE FOR THE INCONVENIENCE THIS HAS CAUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268599 BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 5 F, Y-ADAPTER VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 195-5 30058035 00609038983837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention