BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 7 F, Y-ADAPTER

    MDR report key: 15600889 · Received October 13, 2022

    Report

    Report Number
    8030647-2022-00208
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    July 5, 2022
    Report Date
    January 12, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983851
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30075062, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2022 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 COMP-EHC-22-01053. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 14-NOV-2022 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 (B)(6), 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

    CORRECTION: D4. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30078435, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THE SAMPLE WAS NOT RECEIVED WITH THE ORIGINAL PACKAGING. A BROKEN Y-ADAPTER (3.5 SIZE) WAS RECEIVED WITH THE CLOSED SUCTION CATHETER. ONE SAMPLE WAS RECEIVED WITH LOT 30078435. THE DEVICE WAS EVALUATED. THE FAILURE WAS REPLICATED INTENTIONALLY AFTER THE ASSEMBLY OF THE COMPONENT TO OBTAIN A SIMILAR APPEARANCE AND PATTERN SUCH AS UNIT REPORTED BY THE CUSTOMER. THE ROOT CAUSE WAS MANUFACTURING RELATED. ALL INFORMATION REASONABLY KNOWN AS OF 11-JAN-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, 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.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00209 FOR THE SECOND EVENT. IT WAS REPORTED THE CONNECTION BETWEEN TUBE AND CLOSED SUCTION SYSTEM BROKE. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445961 BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 7 F, Y-ADAPTER VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 197-5 30078435 00609038983851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown