HALYARD SURGICAL CAP BLUE UNIVERSAL SIZE

Additional Manufacturer Narrative

THE COMPLAINT WAS REFERRED TO THE SUPPLIER, (B)(6) FOR INVESTIGATION AND ROOT CAUSE ANALYSIS. THE INVESTIGATION CONFIRMED THAT PRODUCT CODE 69520 IS MADE FROM A NON-WETTABLE MATERIAL THAT DOES NOT ABSORB PERSPIRATION, AS VERIFIED THROUGH PRODUCT DESIGN REVIEW AND SAMPLE TESTING. SINCE THIS MATERIAL IS UNSUITABLE FOR HOT ENVIRONMENTS WHERE MOISTURE ABSORPTION IS NEEDED, IT IS RECOMMENDED THAT CUSTOMERS USE PRODUCT 69240, WHICH IS CONSTRUCTED FROM A WETTABLE MATERIAL SPECIFICALLY DESIGNED TO ABSORB PERSPIRATION. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED PREVIOUSLY, AND NO SAMPLE WAS RETURNED FOR FURTHER EVALUATION. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD SURGICAL CAP, BLUE, UNIVERSAL SIZE. THE COMPLAINT COMPONENT HALYARD SURGICAL CAP, BLUE, UNIVERSAL SIZE, PART NUMBER 69520 IS CONTRACT MANUFACTURED BY JIEHONG MEDICAL PRODUCTS (B)(6) CO. LTD (FDA REGISTRATION NUMBER (B)(4)). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON (B)(6) 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

THE CURRENT CAPS DO NOT ADEQUATELY ABSORB PERSPIRATION, ALLOWING SWEAT TO DRIP INTO THE SURGICAL WOUND, WHICH PRESENTS A QUALITY CONCERN. CUSTOMER INDICATED THE ROOMS ARE HOT IN THE PEDS AREA WHICH IS WHERE ISSUE HAS BEEN REPORTED. ADDITIONAL INCIDENT DETAILS WERE REQUESTED ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026; HOWEVER, NO RESPONSES HAVE BEEN RECEIVED.