BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD SURGICAL CAP BLUE UNIVERSAL SIZE

    MDR report key: 24235031 · Received February 2, 2026

    Report

    Report Number
    3014421917-2026-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Report Date
    March 13, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FYF
    UDI-DI
    30680651695209
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312658 HALYARD SURGICAL CAP BLUE UNIVERSAL SIZE PROTECTIVE APPAREL FYF O&M HALYARD, INC. 69520 UNKNOWN 30680651695209

    Patients

    Seq Age Sex Outcome Treatment
    1