BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP

    MDR report key: 24428293 · Received February 24, 2026

    Report

    Report Number
    1054380-2026-00004
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 27, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341595
    PMA / PMN Number
    K234050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED. THE CIRCLED AREA INDICATED THE PRESENCE OF A HOLE MEASURING APPROXIMATELY 3 MM IN DIAMETER. THE HOLE EXTENDS THROUGH BOTH THE WHITE AND BLUE LAYERS, WITH ALIGNMENT OBSERVED BETWEEN THE TWO. NO ADDITIONAL TEARS, CUTS, OR HOLES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD DATED (B)(6) 2025, CONFIRMED THAT PROCESS ROUND CHECKS FOR FABRIC DEFECTS WERE COMPLETED WITH NO ISSUES DOCUMENTED. ALL QUALITY ATTRIBUTE VISUAL INSPECTIONS WERE RECORDED AS PASSING, AND NO MATERIAL WAS PLACED ON HOLD OR SCRAPPED DUE TO HOLES OR CUTS. BASED ON QUALITY RECORDS, THE MATERIAL MET ALL ESTABLISHED SPECIFICATION REQUIREMENTS. BASED ON THE EVALUATION OF THE DEFECT, REVIEW OF QUALITY DATA, AND ASSESSMENT OF THE MANUFACTURING PROCESS, THE OBSERVED CONDITION IS NOT ATTRIBUTED TO MANUFACTURING. THE PRODUCT IS CONSTRUCTED BY BONDING TWO SEPARATE SHEETS OF MATERIAL (BLUE AND WHITE), WHICH ARE PRODUCED ON DIFFERENT DAYS. THEREFORE, IT IS HIGHLY UNLIKELY THAT BOTH LAYERS WOULD EXHIBIT A PRECISELY ALIGNED HOLE ORIGINATING DURING PRODUCTION. MANUFACTURING PROCESSES AND PRODUCT TESTING ARE CLOSELY MONITORED, AND PERFORMANCE IS EVALUATED THROUGH METRICS SUCH AS COMPLAINTS PER MILLION (CPM) AND TREND ANALYSIS. THIS EVENT WILL BE INCORPORATED INTO THE COMPLAINT REVIEW BOARD¿S ONGOING ANALYSIS TO IDENTIFY POTENTIAL TRENDS. 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 AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS SAID TO BE AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED YET. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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 · 0

    DURING AN ORTHOPEDIC PROCEDURE, A HOLE WAS REPORTED IN THE PRODUCT, RESULTING IN A ONE-HOUR DELAY OF THE SURGERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112911 KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP STERILIZATION PRODUCTS FRG O&M HALYARD, INC. 34159 LR5192 30680651341595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown