BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP, KC 500

    MDR report key: 21548112 · Received March 7, 2025

    Report

    Report Number
    1054380-2025-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 21, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341489
    PMA / PMN Number
    K234050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT DEVICE HISTORY RECORD (DHR) WAS REVIEWED, NO ISSUES WERE DOCUMENTED. ALL QUALITY VISUAL CHECKS WERE DOCUMENTED AS "PASS". NO PRODUCT WAS PLACED ON HOLD FOR FOREIGN MATERIAL OR METAL SHAVINGS. ACCORDING TO QUALITY RECORDS, THIS MATERIAL MET SPECIFICATION GUIDELINES. A ROOT CAUSE COULD NOT BE DETERMINED. 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. THIS INCIDENT HAS BEEN COMMUNICATED TO THE MANUFACTURING TEAMS AND WILL BE INCLUDED IN OUR TREND ANALYSIS TO MONITOR FOR ANY CORRECTIVE ACTION NEEDS. 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

    THE SAMPLE IS 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

    CUSTOMER STATED THAT WHILE WRAPPING A TRAY FOR STERILIZATION, SHE FOUND METAL SHAVINGS IN THE STERILIZATION WRAP. A METAL SHAVING POKED HER AND BROKE THE SKIN ON HER FINGER. THE CUSTOMER WAS NOT ABLE TO LOCATE THE METAL SHAVING FOR EVALUATION. A SECONDARY ISSUE FOR STERILIZATION WRAP WAS COMMUNICATED, THE DAISY PATTERN WAS RAISED AND THERE WAS LINTING OBSERVED. THIS CAUSED A TWO-HOUR DELAY. NO CASES WERE CANCELED. THE CUSTOMER STATED THEY RESOLVED THE ISSUE BY OPENING NEW TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905892 KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP, KC 500 STERILIZATION PRODUCTS FRG O&M HALYARD, INC. 34148 LT4280 30680651341489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown