BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN

    MDR report key: 24234235 · Received February 2, 2026

    Report

    Report Number
    3014421917-2026-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 12, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    PUI
    UDI-DI
    30680651797583
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN. 62 IN. 254 CM 157. THE COMPLAINT COMPONENT HALYARD BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN. 62 IN.254 CM 157, PART NUMBER 79758 IS CONTRACT MANUFACTURED BY GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. (FDA REGISTRATION NUMBER 3004911384). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON JANUARY 19, 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DETAILS WERE FORWARDED TO THE APPROPRIATE FUNCTIONAL AREA FOR INVESTIGATION AND ROOT CAUSE DETERMINATION. NO COMPLAINT SAMPLE OR SUPPORTING PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETAINED SAMPLE REVEALED NO ABNORMALITIES, AND A REVIEW OF THE PRODUCTION RECORDS IDENTIFIED NO NONCONFORMITIES; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. PRODUCTION RECORDS CONFIRMED THAT OPERATORS PERFORMED ALL MANUFACTURING STEPS IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND SPECIFICATIONS. THE PROCESS INCLUDED POUCHING THE SMS MATERIAL, APPLYING DOUBLE-SIDED TAPE, GLUING THE TUBE HOLDER, AND ATTACHING THE POUCH TO THE SMS MATERIAL. NO NONCONFORMITIES WERE IDENTIFIED DURING THESE MANUFACTURING STEPS. QUALITY INSPECTIONS INCLUDED VISUAL EXAMINATIONS FOR LOOSE MATERIAL, TEARS, DAMAGE, AND OTHER POTENTIAL DEFECTS. NO NONCONFORMITIES WERE OBSERVED DURING SAMPLING INSPECTION. A REVIEW OF COMPLAINT HISTORY FROM JANUARY 2025 THROUGH JANUARY 2026 INDICATED THIS IS THE FIRST COMPLAINT RELATED TO A SURGICAL DRAPE FALLING APART FOR PRODUCTS MANUFACTURED ON THE SAME PRODUCTION LINE. BASED ON THE INVESTIGATION RESULTS, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(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

    CONCERNS HAVE BEEN RAISED REGARDING THE QUALITY OF THE DRAPES, AS THEY HAVE BEEN OBSERVED TO DETERIORATE DURING USE, RESULTING IN FRAGMENTS ENTERING OPEN SHOULDER WOUNDS. THE COMPLAINANT HAS INDICATED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293100 HALYARD BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN SURGICAL DRAPES AND PACKS PUI O&M HALYARD, INC. 79758 UNKNOWN 30680651797583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown