BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMGUARD ONESTEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN

    MDR report key: 16989423 · Received May 23, 2023

    Report

    Report Number
    1054380-2023-00001
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 19, 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
    KY, 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

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. ACCORDING TO THE CUSTOMER, THESE WET PACKS WERE FOUND POST-STERILIZATION. WITH THE INCIDENT OCCURRING POST-STERILIZATION, IT'S UNCLEAR WHAT CONTRIBUTING FACTORS THE END-USER UTILIZED WHEN FURTHER PROCESSING THE WRAP WHICH MAY HAVE CONTRIBUTED TO THE PRODUCT ISSUE. CUSTOMER COMPLAINTS ARE REVIEWED MONTHLY DURING COMPLAINT REVIEW BOARD WHICH UTILIZES METRICS INCLUDING CPM(COMPLAINT PER MILLION) AND TREND ANALYSIS TO MONITOR THE EFFECTIVENESS OF PROCESS AND QUALITY CONTROL. GIVEN THERE WAS NO LOT NUMBER PROVIDED, THE SITE IS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS TO DETERMINE IF THERE WAS ANY ISSUE THAT OCCURRED DURING MANUFACTURE THAT MAY CONTRIBUTE. 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.

    Description of Event or Problem · 0

    INCIDENT ONE. CUSTOMER REPORTED THEY HAVE EXPERIENCED WET PACKS. THIS RESULTED IN PATIENT DELAY IN PROCEDURE. ADDITIONAL INCIDENT DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650921 KIMGUARD ONESTEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN HALYARD* QUICK CHECK* STERILIZATION WRAP FRG O&M HALYARD, INC. 34164 UNKNOWN 30680651341649

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other