BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS MEDICAL, INC

    MDR report key: 22514759 · Received July 15, 2025

    Report

    Report Number
    8030647-2025-00069
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Report Date
    December 5, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038983837
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 15 JUL 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE; ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE CONFIRMED THE COMPLAINT AS REPORTED. BASED ON THE EVIDENCE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS BEEN ESTABLISHED TO BE LACK OF SOLVENT CAUSED BY DAMAGE IN THE EQUIPMENT THAT DISPENSES THE SOLVENT DURING THE CONTROL VALVE ASSEMBLY PROCESS. IN ORDER TO PREVENT THIS ISSUE FROM REOCCURRING, THE PROCESS FOR THE SEMI-ANNUAL PREVENTIVE MAINTENANCE OF AUTOVALVES:1, 2 & 3 WILL BE UPDATED TO ADD THE CHANGE OF SOLVENT DISPENSING LINES TO INCLUDE ALL STATIONS. THE DEVICE HISTORY RECORD FOR LOT 1586737 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 05 DEC 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE INLINE SUCTION CATHETER BROKE (THE TWIST ON/OFF KNOB BROKE); THERE WAS NO REPORTED INJURY TO THE PATIENT WHO DID NOT REQUIRE FREQUENT SUCTIONING.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE INLINE SUCTION CATHETER BROKE (THE TWIST ON/OFF KNOB BROKE); THERE WAS NO REPORTED INJURY TO THE PATIENT WHO DID NOT REQUIRE FREQUENT SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137425 AVANOS MEDICAL, INC BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 98383 1586737 00609038983837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown