BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ELASTOMERIC PUMP

    MDR report key: 24840898 · Received April 10, 2026

    Report

    Report Number
    2026095-2026-00025
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Report Date
    April 10, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 10-APR-2026 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

    IT WAS REPORTED THE FAMILY INQUIRED "ABOUT DETAILS ON HOW THE ONQ WORKS. [CAREGIVER] WASN'T FAMILIAR WITH IT. [THE CAREGIVER] SAID HER BROTHER HAD IT WITH A ¿NEEDLE IN HIS NECK¿ AFTER A SHOULDER SURGERY...IT WAS A CATHETER FOR MEDICATION INFUSION INTO SURGICAL SITE TO REDUCE PAIN. [CAREGIVER] STATED THAT HER BROTHER DIED THE NEXT DAY AFTER THE SIMPLE OUTPATIENT SURGERY AND THEY ARE TRYING TO FIGURE OUT WHAT WENT WRONG. HE PASSED ON (B)(6), AUTOPSY PENDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900416 UNKNOWN ELASTOMERIC PUMP ELASTOMERIC - SAF MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| O