BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48 IN

    MDR report key: 24222508 · Received January 30, 2026

    Report

    Report Number
    1054380-2026-00002
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 23, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341465
    PMA / PMN Number
    K234050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS SAID TO BE AVAILABLE FOR EVALUATION BUT NOT RECEIVED YET. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE 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 21 CFR 803, 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

    (B)(4) UNUSED SAMPLES WERE RECEIVED WITHOUT PACKAGING AND WERE EVALUATED UNDER AMBIENT LIGHTING CONDITIONS. THE BLUE LAYER OF EACH SAMPLE CONTAINED SEVERAL AREAS CIRCLED IN PINK INK. WITHIN THESE CIRCLED AREAS, DARK SPOTS WERE OBSERVED MEASURING APPROXIMATELY 1 MM OR LESS, APPEARING SIMILAR TO MELTED POLYMER. ONE SPOT FROM EACH SAMPLE WAS EXAMINED UNDER MAGNIFICATION. THE DARK SPOTS APPEAR TO BE MELTED POLYMER LOCATED AROUND THE BOND POINTS. A HOLE WAS OBSERVED IN ONE OF THE MELTED POLYMER AREAS. THE WHITE LAYERS WERE NOT AFFECTED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE BLUE ROLLS WERE PRODUCED ON (B)(6) 2025. QUALITY RECORDS, ATTRIBUTE DATA, AND VISUAL INSPECTIONS FOR THESE ROLLS WERE DOCUMENTED AS ACCEPTABLE. A REVIEW OF THE MACHINE SPINNING LOGBOOK IDENTIFIED NO ABNORMAL CONDITIONS THAT WOULD SUPPORT THE OCCURRENCE OF THIS TYPE OF SPINNING ISSUE. BASED ON THE TRACK AND TREND TOOL, THE MOVING AVERAGE FOR THIS DEFECT IS APPROXIMATELY 1.75 CPM, WITH NO ADVERSE TREND OBSERVED OVER THE PAST 12 MONTHS. ONGOING PREVENTIVE MEASURES, CONTROLS, AND INSPECTIONS ARE IN PLACE, INCLUDING VISUAL INSPECTIONS THAT SUPPORT WEB INSPECTION SYSTEMS, AS WELL AS LOOK AND FEEL QUALITY WALK-THROUGHS CONDUCTED BY PRODUCTION TEAM MEMBERS TO IDENTIFY ANY DEVIATIONS ACROSS THE PRODUCTION ASSET. ADDITIONALLY, HISTORIAN AND CENTERLINE SYSTEMS ARE UTILIZED TO ENSURE CRITICAL QUALITY VARIABLES ARE MAINTAINED, WITH ANY DEVIATIONS ESCALATED AND ADDRESSED SYSTEMATICALLY. VISUAL CHECKS ARE ALSO PERFORMED AT EVERY ROLL CHANGE TO DETECT ANY FOREIGN MATERIAL OR DEFECTS. 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

    WRAPPING SHEETS EXHIBITED MICRO-PERFORATIONS AFTER STERILIZATION AND WERE ALREADY DAMAGED UPON REMOVAL FROM THE PACKAGE PRIOR TO USE. AS A RESULT, MULTIPLE SURGICAL PROCEDURES WERE DELAYED AFTER PATIENTS WERE ALREADY POSITIONED ON THE OPERATING TABLE. ADDITIONAL DETAILS (INCLUDING PATIENT DETAILS FOR THOSE AFFECTED) HAVE BEEN REQUESTED; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282950 KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48 IN STERILIZATION PRODUCTS FRG O&M HALYARD, INC. 34146 LT5247 30680651341465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other