BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24222485 · Received January 30, 2026

    Report

    Report Number
    1054380-2026-00001
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 18, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341458
    PMA / PMN Number
    K234050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 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

    THREE UNUSED SAMPLES WERE RECEIVED FOR EVALUATION. BASED ON THE ATTACHED PHOTOGRAPHS AND SAMPLE ASSESSMENT, THE MATERIAL EXHIBITS DEFECTS ON THE BLUE LAYER AROUND THE BOND POINTS, LIKELY CAUSED BY POOR SPINNING IN THE FORM OF SPITTERS. NO HOLES WERE OBSERVED IN THE INSPECTED DEFECT AREAS, AND THE WHITE LAYERS DO NOT APPEAR TO BE AFFECTED. ALL THREE SAMPLES ARRIVED WITH AREAS OF CONCERN CIRCLED IN PINK INK ON THE BLUE LAYER. WITHIN THESE CIRCLED AREAS, DARK BLUE SPOTS MEASURING APPROXIMATELY 1 MM OR LESS WERE OBSERVED, PRIMARILY AROUND THE BOND POINTS. ONE DARK SPOT FROM EACH SAMPLE WAS EXAMINED UNDER MAGNIFICATION. ALTHOUGH NO OBVIOUS HOLES WERE IDENTIFIED DURING THE INSPECTION, THE PRESENCE OF BREACHES WITHIN THE DAMAGED AREAS CANNOT BE COMPLETELY RULED OUT. THE WHITE LAYERS REMAIN UNAFFECTED. HARD SPOTS/SPITTERS ARE SPINNING DEFECTS INHERENT TO THE MANUFACTURING PROCESS. THEY CAN OCCUR WHEN POLYMER FIBERS BREAK DURING EXTRUSION, WHEN TURBULENCE AFFECTS THE WEB, OR WHEN EXCESSIVE TEMPERATURES CAUSE POLYMER GRANULES TO HARDEN AND CLOG THE EXTRUSION TIPS. THESE CLOGS INCREASE EXTRUDER PRESSURE UNTIL IT RELEASES, PUSHING SMALL HARDENED PARTICLES (SPITTERS) ONTO THE SHEET. WHEN SUCH CONDITIONS ARE OBSERVED DURING VISUAL INSPECTIONS, PRODUCTION ASSOCIATES IMMEDIATELY NOTIFY THE APPROPRIATE PERSONNEL TO DETERMINE CORRECTIVE ACTIONS. CONTROLS USED TO MINIMIZE POLYMER BLEMISHES INCLUDE ESTABLISHED PROCESS SETTINGS WITH DEFINED LIMITS, CENTER LINING CONTROL PLANS, AUTOMATED PROCESS MONITORING SYSTEMS, AND STATISTICAL PROCESS CONTROLS. PROCESS AND PRODUCT TESTING RESULTS ARE CLOSELY MONITORED TO GUIDE ACTIONS. CUSTOMER FEEDBACK IS REVIEWED BY THE COMPLAINT REVIEW BOARD, WHICH USES METRICS SUCH AS CPM (COMPLAINTS PER MILLION) AND TREND ANALYSIS TO EVALUATE PROCESS AND QUALITY PERFORMANCE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR 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
    282691 KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48 IN STERILIZATIONS PRODUCTS FRG O&M HALYARD, INC. 34145 LT5028000 30680651341458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other