BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN

    MDR report key: 17749067 · Received September 14, 2023

    Report

    Report Number
    1054380-2023-00006
    Event Type
    Injury
    Date Received
    September 14, 2023
    Report Date
    October 30, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341649
    PMA / PMN Number
    K214007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT WAS REVIEWED BY THE MANUFACTURING SITE. THE CUSTOMER STATED, "HOLES IN THE WRAP POST STERILIZATION". THERE WERE NO QNC EVENTS ASSOCIATED WITH THE COMPLAINT LOT, DEVICE HISTORY RECORD REVIEW FOUND THE PRODUCT MET MANUFACTURING SPECIFICATION AT RELEASE. 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 WILL BE INCLUDED IN OUR COMPLAINT REVIEW ANALYSIS TO HELP IDENTIFY ANY EMERGING TRENDS. A ROOT CAUSE WAS NOT IDENTIFIED. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE FOR RETURN. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE FACILITY HAS EXPERIENCED HOLES IN THE WRAP POST STERILIZATION. THEY ARE USING CORNER PROTECTORS, AND THE HOLES ARE OCCURRING ON THE MIDDLE AND SIDES OF THE WRAPS ON THE WHITE SIDE. THE CUSTOMER CONFIRMED THE WEIGHT OF THE TRAYS ARE 17-25 POUNDS AND THEY ARE USING THE WRAPS ACCORDING TO THE INSTRUCTIONS FOR USE. THE CUSTOMER STATED THEY EXPERIENCED A DELAY IN A PROCEDURE THAT LAST LESS THAN A HALF HOUR. IT WAS RESOLVED BY TAKING A TRAY FROM ANOTHER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220718 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN HALYARD* QUICK CHECK* STERILIZATION WRAP FRG O&M HALYARD, INC. 34164 LT3121000 30680651341649

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other