BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT-MED

    MDR report key: 15921372 · Received December 5, 2022

    Report

    Report Number
    1423537-2022-00865
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    October 22, 2022
    Report Date
    December 5, 2022
    Manufacturer
    NINGBO LUKE MEDICAL DEVICES CO., LTD
    Product Code
    KGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER, N210469. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS FOR ANY OF THE FOURTEEN PRODUCT NUMBERS ASSOCIATED WITH THE REPORTED LOT. CUSTOMER DID NOT PROVIDE THE CORRESPONDING PRODUCT NUMBER OR RETURN ANY SAMPLES FOR INVESTIGATION. SINCE NO SAMPLES WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. SUPPLIER TESTED THE CONNECTION STRENGTH AND BREAKING STRENGTH OF RETAINED SAMPLES FROM THE REPORTED LOT. THE TEST RESULTS CONFIRMED THIS LOT MEETS THE PRODUCTS SPECIFICATIONS. THE SITE WILL CONTINUE TO MONITOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    JACKSON-PRATT DRAIN REMOVED BUT PERFORATED DISTAL PORTION OF THE DRAIN DISCONNECTED FROM THE CLEAR TUBING AND REQUIRED REMOVAL BY PHYSICIAN AT BEDSIDE WITH HEMOSTATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112590 UNKNOWN PRODUCT-MED ACCESSORIES, CATHETER KGZ NINGBO LUKE MEDICAL DEVICES CO., LTD UNKNOWN PRODUCT-MED N210469

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown