BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 12962096 · Received December 8, 2021

    Report

    Report Number
    2916714-2021-00231
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 11, 2021
    Report Date
    March 17, 2023
    Manufacturer
    AESCULAP INC.
    Product Code
    KCT
    UDI-DI
    05055049091927
    PMA / PMN Number
    K890759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION: ALTHOUGH THE DEVICE WAS RETURNED BY THE COMPLAINANT, THE SAMPLE WAS LOST DURING SHIPMENT. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. ALTHOUGH THE LOT NUMBER OF THE LOCK WAS PROVIDED, THE INDICATOR LOT # WAS NOT AVAILABLE. THEREFORE, THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION OR INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A STEAM STER LOCKS ORANGE. IT WAS NOTED THAT THE ORANGE LOCKS DOES NOT CHANGE COLOR WHEN GOING THROUGH STERILIZATION. BLUE DOES NOT CHANGE TO BROWN. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED MEDWATCH-REPORTS: 2916714-2021-00230 ((B)(4) - US906).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862232 STEAM STER LOCKS ORANGE STERILE TECHNOLOGY KCT AESCULAP INC. US906 617431-01 05055049091927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown