BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUOHY EPIDURAL NEEDLE 25EA/BOX-18324

    MDR report key: 24903969 · Received April 16, 2026

    Report

    Report Number
    2026095-2026-00031
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    May 8, 2025
    Report Date
    April 16, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSP
    UDI-DI
    00193493905812
    PMA / PMN Number
    K000495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14-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 VIA FDA MEDWATCH / FDA USER FACILITY REPORTS MW REPORT MW5172266 AND THE FOLLOWING INFORMATION WAS PROVIDED: DURING A ROUTINE L4 L5 LUMBAR EPIDURAL STEROID INJECTION USING A 20-GAUGE, 4.5-INCH SPINAL NEEDLE, I OBSERVED THAT THE NEEDLE FRACTURED NEAR THE HUB DURING ADVANCEMENT, LEAVING A PORTION OF THE NEEDLE RETAINED IN THE PATIENT'S SOFT TISSUE. UNDER STERILE TECHNIQUE AND FLUOROSCOPIC GUIDANCE, DOCTOR (DR.) CAREFULLY LOCATED AND SUCCESSFULLY REMOVED THE RETAINED NEEDLE FRAGMENT. THE PATIENT REMAINED STABLE AND COOPERATIVE THROUGHOUT THE PROCEDURE. NO SEDATIVES OR ADDITIONAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957738 TUOHY EPIDURAL NEEDLE 25EA/BOX-18324 PAIN MANAGEMENT KITS/TRAYS/NEEDLES BSP AVANOS MEDICAL INC. 18324 30350230 00193493905812

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female