TUOHY EPIDURAL NEEDLE 25EA/BOX-18324

Additional Manufacturer Narrative

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

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.