HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL

Additional Manufacturer Narrative

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. THE COMPLAINT COMPONENT HALYARD HI GUARD ULTRA FULL COVERAGE BOOT, UNIVERSAL, PART NUMBER 69572 IS 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 16, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE 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 21CFR803, 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.

Description of Event or Problem

THE TRACTION BLACK STRIP ON THE BOTTOM OF THE BOOT COVER WAS REPORTED TO PEEL OFF WHILE STAFF WERE IN THE PATIENT¿S ROOM PERFORMING ROUTINE NURSING CARE. AS A RESULT, THE BOOT COVERS WERE PERCEIVED AS SLIPPERY, SLOWING STAFF MOVEMENT, PARTICULARLY IN HIGH-LEVEL INFECTIOUS DISEASE SETTINGS DUE TO CONCERNS ABOUT POTENTIAL SLIPS OR FALLS.