BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK CHECK H600 STERILIZATION WRAP 45IN X 45IN

    MDR report key: 19634149 · Received June 28, 2024

    Report

    Report Number
    1054380-2024-00009
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 6, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    90680651341641
    PMA / PMN Number
    K214007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT FOUR OF SIX. A SAMPLE WAS NOT PROVIDED FOR EVALUATION. POSSIBLY, THIS WAS A WATERMARK OR MOISTURE STAIN THAT HAS DRIED A DARKER BLUE COLOR THAN THE NORMAL COLOR. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR COMPLAINT LOT. NO ISSUES WERE DOCUMENTED, THE RECORDS INDICATE PRODUCT MET ALL QUALITY SPECIFICATIONS PRIOR TO RELEASE. VISUAL CHECKS WERE DOCUMENTED AS PASS. NO PRODUCTS FROM LOT WERE PLACED ON HOLD OR SCRAPPED DUE TO QUALITY ISSUES. RESULTS OF THE MANUFACTURING PROCESS AND PRODUCT TESTING ARE CLOSELY MONITORED AND USED TO DRIVE ACTIONS. 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 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 FOUR. 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

    INCIDENT FOUR. STERILIZATION WRAP EXHIBITED STAINING. FACILITY HAS USED PRODUCT FOR SEVERAL YEARS. THE FACILITY HAS NOT CHANGED THEIR STERILIZATION PROCESS OR PARAMETERS. TRAYS WERE REJECTED BY THE OR AND SIX SURGICAL CASES WERE CANCELLED. ADDITIONALLY, SEVERAL CASES WERE DELAYED UP TO 2-3 HOURS. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. IN TWO SURGICAL CASES, 2 PATIENTS RECEIVED A BLOCK PRIOR TO THE SURGERY BEING CANCELLED. THE PATIENTS WERE PARALYZED FOR SIX HOURS FROM THE WAIST DOWN UNTIL THE MEDICATION WORE OFF. THE CASES WERE RE-SCHEDULED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED FOR THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816097 QUICK CHECK H600 STERILIZATION WRAP 45IN X 45IN STERILIZATION PRODUCTS FRG O&M HALYARD, INC. 34164 LT4091 90680651341641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other