BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP

    MDR report key: 21911174 · Received April 25, 2025

    Report

    Report Number
    1054380-2025-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 3, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341649
    PMA / PMN Number
    K234050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TWO THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED. 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 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

    INCIDENT TWO. ONE USED SAMPLE WAS RECEIVED. A LARGE RECTANGULAR STAIN IS OUTLINED IN THE MIDDLE OF THE WRAP WHERE AN INSTRUMENT TRAY MAY HAVE RESTED. THE STAIN PENETRATED BOTH BLUE AND WHITE LAYERS IN A CORRESPONDING OUTLINE. MANUFACTURING SITE REVIEWED THE DEVICE HISTORY RECORD FOR COMPLAINT LOT. SITE REVIEWED PRODUCTION RECORDS FOR FABRIC DEFECTS, AND NO ISSUES HAD BEEN DOCUMENTED. ALL QUALITY ATTRIBUTE VISUAL CHECKS WERE DOCUMENTED AS PASS ON THESE ROLLS. NO MATERIAL HAD BEEN PLACED ON HOLD OR SCRAPPED FOR MATERIAL DEFECTS OR STAINS. ACCORDING TO THE QUALITY RECORDS, THIS MATERIAL MET SPECIFICATION GUIDELINES. CUSTOMER FEEDBACK IS REVIEWED BY THE COMPLAINT REVIEW BOARD WHICH UTILIZES METRICS SUCH AS CPM (COMPLAINTS PER MILLION) AND TREND ANALYSIS TO MONITOR THE EFFECTIVENESS OF THE PROCESS AND QUALITY CONTROL. CURRENTLY THERE ARE 1.4 COMPLAINTS PER MILLION FOR THIS PRODUCT, THIS DOES NOT WARRANT FURTHER ACTIONS. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. A ROOT CAUSE WAS NOT IDENTIFIED. THE STAINS WERE INDICATIVE OF SOME TYPE OF REACTION WITH THE INSTRUMENT TRAY THE END-USER WAS STERILIZING. THE STERILIZATION MATERIALS AND PROCESS UTILIZED BY THE CUSTOMER IS UNKNOWN. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RUST STAINING ON WRAP WHERE THE TRAY WAS SITTING. ADDITIONAL INFORMATION REPORTED ON APRIL 15, 2025, STATES, THERE WERE A COUPLE OF PROCEDURE CANCELLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811638 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP SURGICAL PRODUCTS FRG O&M HALYARD, INC. 34164 LT4306 30680651341649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown