BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS

    MDR report key: 16473459 · Received March 2, 2023

    Report

    Report Number
    8030647-2023-00034
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 27, 2023
    Report Date
    May 8, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038924311
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED AND REVIEWED. UPON FURTHER REVIEW, AVANOS MEDICAL INC. CONCLUDED A TACTILE SLEEVE ON A CLOSED SUCTION CATHETER (CSC) THAT IS PERCEIVED TO BE THICKER THAN USUAL MAKING IT DIFFICULT TO SEE THE DEPTH MARKINGS WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THIS COMPLAINT WAS DOWNGRADED TO A NOT REPORTABLE EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 08MAY 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 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 ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 MAR 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 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED, THE PATIENT DID NOT REPORT ANY SERIOUS INJURY OR INCIDENT, "JUST THE PERCEPTION OF THE THICKER SLEEVE MAKING IT DIFFICULT TO SEE THE DEPTH MARKING." THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    FDA MEDWATCH / FDA USER FACILITY REPORT MW5114586 REPORTED, THE CLOSED SUCTION CATHETER WAS TOO THICK AND HAD TOO MUCH PLASTIC AND THEY WERE UNABLE TO INSERT THE CATHETER AND SUCTION PROPERLY. AN UNSPECIFIED SERIOUS INJURY WAS SELECTED; HOWEVER, THE DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION RECEIVED 14FEB2023 THE PARENT REPORTED, THEY WERE UNABLE TO SUCTION THEIR CHILD TO THE DEPTH OF 16ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012064 BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 20083 30207636 00609038924311

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male