BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 36IN X 36IN

    MDR report key: 16988869 · Received May 23, 2023

    Report

    Report Number
    1054380-2023-00002
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 20, 2023
    Report Date
    July 3, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FRG
    UDI-DI
    30680651341991
    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 SAMPLE WAS NOT RETURNED FOR EVALUATION. ACCORDING TO THE CUSTOMER, THESE WET PACKS WERE FOUND POST-STERILIZATION. WE ARE UNABLE TO IDENTIFY A ROOT CAUSE. NO FURTHER ACTIONS WILL BE TAKEN. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    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.

    Description of Event or Problem · 0

    INCIDENT TWO. 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
    1450398 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 36IN X 36IN HALYARD* QUICK CHECK* STERILIZATION WRAP FRG O&M HALYARD, INC. 34199 UNKNOWN 30680651341991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other