HALYARD HI GUARD ULTRA FULL COVERAGE BOOT, UNIVERSAL

Description of Event or Problem

TRACTION STRIPS COMING OFF THE HALYARD BOOT COVERS. ISOLATED TO STERILE PROCESSING DEPARTMENT. NO PATIENTS WERE INVOLVED; ALTHOUGH TWO STAFF MEMBERS HAVE FALLEN. ONE WENT TO THE ER. NO MEDICAL TREATMENT OR ADMISSION WAS REQUIRED. THEY HIT THEIR HEAD AND FELL ON ELBOW.

Additional Manufacturer Narrative

INCIDENT 1 OF 2. THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL, PART NUMBER 69572 CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER 3011547453). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON APRIL 27, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE CONTRACT MANUFACTURER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.