BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 48IN X 48IN

    MDR report key: 17076048 · Received June 6, 2023

    Report

    Report Number
    1054380-2023-00005
    Event Type
    Injury
    Date Received
    June 6, 2023
    Report Date
    July 19, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341489
    PMA / PMN Number
    K214007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    A SAMPLE OR A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. ROOT CAUSE WAS NOT IDENTIFIED. WALK-THROUGH INSPECTIONS ARE REGULARLY PERFORMED. IN THE EVENT AN ISSUE IS DETECTED, THE EQUIPMENT IS EVALUATED FOR ANY MAINTENANCE NEEDS. ALL MATERIAL IS REWORKED SINCE THE LAST ACCEPTABLE WALK-THROUGH INSPECTION. THIS INCIDENT WILL BE INCLUDED IN COMPLAINT REVIEW ANALYSIS TO HELP IDENTIFY ANY EMERGING TRENDS. 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

    CUSTOMER STATED, THEY HAD A DELAY IN SURGERY DUE TO TEARS IN THE WRAP (DURING USE WITH PATIENTS IN THE OPERATING ROOM). THIS WAS RESOLVED BY REPLACING THE TRAYS. IN ONE INSTANCE THE TRAY WAS ONE OF A KIND AND THEY HAD TO WAIT AN HOUR AND A HALF FOR STERILE PROCESSING TO REPLACE THE TRAY. NO INJURY WAS REPORTED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA. NO INSTRUMENTS FROM THE TRAYS WERE REPORTED AS USED ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094360 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 48IN X 48IN STERILIZATION WRAP FRG O&M HALYARD, INC. 34148 UNKNOWN 30680651341489

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other