BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK CHECK STERILIZATION WRAP

    MDR report key: 23260465 · Received October 9, 2025

    Report

    Report Number
    1054380-2025-00011
    Event Type
    Injury
    Date Received
    October 9, 2025
    Report Date
    December 9, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT EIGHT OF ELEVEN. THE MANUFACTURING SITE AND SUPPORTING TEAMS REVIEWED MANUFACTURING CONTROLS, COMPLAINT SAMPLES, AND POST-MANUFACTURING HANDLING PROCESSES¿INCLUDING CENTRAL STERILE SERVICES DEPARTMENT ACTIVITIES AND TRANSPORTATION¿TO IDENTIFY THE MOST LIKELY POINT OF ORIGIN. MANUFACTURING CONTROLS INCLUDE ESTABLISHED CONTROL PLANS, AUTOMATED PROCESS-MONITORING SYSTEMS, ONLINE VISION-INSPECTION SYSTEMS, AND STATISTICAL IN-PROCESS SAMPLING PLANS THAT EVALUATE VISUAL DEFECTS AS WELL AS BARRIER AND PERFORMANCE ATTRIBUTES. THE SAMPLING PLANS AND ACCEPTANCE CRITERIA ARE DESIGNED TO MINIMIZE THE LIKELIHOOD OF DEFECTS REACHING CUSTOMERS. USERS ARE ALSO TRAINED TO PERFORM VISUAL INSPECTIONS BEFORE PRODUCT USE, AND HISTORICAL COMPLAINTS INDICATE THAT DEFECTS HAVE GENERALLY BEEN DETECTED PRIOR TO USE. NO HISTORICAL COMPLAINTS RELATED TO PATIENT INFECTION HAVE BEEN ASSOCIATED WITH THE USE OF THIS PRODUCT. A ROOT CAUSE WAS NOT IDENTIFIED. THE NONSTERILE PRODUCT IS SHIPPED TO CUSTOMERS WHOM UTILIZE THE PRODUCT TO WRAP SURGICAL TRAY AND STERILIZE ACCORDING TO HOSPITAL INTERNAL CENTRAL STERILE SERVICES DEPT VALIDATION PROTOCOL. 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

    INCIDENT EIGHT OF ELEVEN. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. 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

    THE HEALTH AND YOUTH CARE INSPECTORATE (IGJ) OF THE NETHERLANDS HAS BEEN NOTIFIED OF ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH HALYARD STERILIZATION WRAP. THESE INCIDENTS WERE REPORTED AT THE HELENA SCHWEITZER CLINIC, AFFILIATED WITH THE ALBERT SCHWEITZER HOSPITAL, AND OCCURRED WITHIN THE TIME FRAME OF (B)(6) 2025. FOLLOWING THIS PERIOD, THE HEALTHCARE INSTITUTION REPORTED THAT ELEVEN PATIENTS DEVELOPED DEEP POSTOPERATIVE INFECTIONS SUBSEQUENT TO TOTAL HIP ARTHROPLASTY PROCEDURES PERFORMED DURING THE AFOREMENTIONED TIMEFRAME. OWENS & MINOR WAS NOT PREVIOUSLY AWARE OF ANY INCIDENTS REPORTING PATIENT INFECTION. ON (B)(6) 2025, A MEETING WAS CONDUCTED WITH ALBERT SCHWEITZER HOSPITAL REPRESENTATIVES. DURING THIS MEETING, THE REPRESENTATIVES INDICATED THAT THEY WERE NOT PREVIOUSLY AWARE OF THIS SPECIFIC NOTIFICATION AND WERE UNABLE TO VERIFY THE ASSOCIATED PRODUCT CODE(S) OR LOT NUMBER(S) IMPLICATED IN THE REPORT. THIS HOSPITAL SYSTEM PREVIOUSLY HAS REPORTED COMPLAINTS FOR HARD SPOTS AND HOLES ON THE WRAP IN EARLY 2025. THOSE COMPLAINTS WERE LOGGED AND INVESTIGATED, EACH INCIDENT PREVIOUSLY COMMUNICATED INDICATED THERE WAS NO PATIENT IMPACT AS THE ISSUE WAS NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173698 QUICK CHECK STERILIZATION WRAP QUICK CHECK STERILIZATION WRAP FRG O&M HALYARD, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other