BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS WITH BALLARD TECHNOLOGY

    MDR report key: 11680577 · Received April 16, 2021

    Report

    Report Number
    8030647-2021-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Report Date
    May 6, 2021
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE REVEALED NO DAMAGE. THE THUMB VALVE WAS TESTED AND NO LEAKS COULD BE DETECTED. THE REPORTED EVENT COULD NOT BE REPRODUCED, AND THEREFORE THE COMPLAINT IS NOT CONFIRMED. NO ROOT CAUSE COULD BE DETERMINED. 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 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

    PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2021, ALL THREE REPORTED EVENTS INVOLVED THE SAME PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT 30078439 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 12 APR 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2021-00009 FOR THE SECOND REPORT. REFER TO 8030647-2021-00010 FOR THE THIRD REPORT. IT WAS REPORTED THAT DURING FLUSHING OF THE CLOSED SUCTION CATHETER, THE PHYSIOLOGICAL SERUM WAS NOT REMOVED BY THE SUCTION CATHETER, AND INSTEAD FELL BACK INTO THE ENDOTRACHEAL TUBE. THE NURSE PERFORMED SUCTION WITH AN OPEN CATHETER INSTEAD. PATIENT WEIGHTS 860 GRAMS PER ADDITIONAL INFORMATION RECEIVED 24 MAR 2021, THE PATIENT WAS NOT INJURED AND THERE WAS NO NEED FOR ANY MEDICAL TREATMENT. PER ADDITIONAL INFORMATION RECEIVED 30 MAR 2021, THE PATIENT DID EXPERIENCE OXYGEN DESATURATION. AFTER CONVENTIONAL SUCTION WAS PERFORMED, THE PATIENT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576655 BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS WITH BALLARD TECHNOLOGY VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 196-5 30078439

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA