BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP CHAN DRN SIL FLT 7MM FULL W/TRO

    MDR report key: 16907876 · Received May 10, 2023

    Report

    Report Number
    1423537-2023-00935
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 30, 2023
    Report Date
    May 10, 2023
    Manufacturer
    NINGBO LUKE MEDICAL DEVICE CO LTD
    Product Code
    KGZ
    UDI-DI
    10885380182495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON SUPPLIER INVESTIGATION, NO LOT NUMBER, SAMPLE PHOTO, OR RETURNED SAMPLE WAS PROVIDED FOR INVESTIGATION. THE SUPPLIER CANNOT CONFIRM THE COMPLAINT PRODUCT IS PRODUCED BY THEM. HOWEVER, SUPPLIER REVIEWED THE LAST 3 LOT NUMBERS SHIPPED N210368, N210468 AND N220050. THERE IS NO ABNORMALITY FOUND DURING PRODUCTION AND INSPECTION. SUPPLIER TESTED THE RETAINED SAMPLES FROM LAST 3 LOT NUMBERS SHIPPED. THE CONNECTION STRENGTH TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. THESE PRODUCTS ARE DISPOSABLE AND CANNOT BE REUSED. ICONS ARE INDICATED IN THE LABELS. BASED ON TESTING AND THE INFORMATION PROVIDED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING REMOVAL OF JP DRAIN FROM THE PATIENT'S SCALP, THE JUNCTION BETWEEN THE CLEAR DRAIN TUBING AND FLUTED WHITE PIECE APPEARED TO BE SEVERED AND EMERGED FROM SCALP, LEAVING THE LENGTH OF THE SUBGALEAL PORTION RETAINED IN THE WOUND. THIS IS THE 3RD EVENT THAT THIS HAS HAPPENED AT OUR INSTITUTION WITH THE SAME DRAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199479 JP CHAN DRN SIL FLT 7MM FULL W/TRO ACCESSORIES, CATHETER KGZ NINGBO LUKE MEDICAL DEVICE CO LTD JP-2212 UNKNOWN 10885380182495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown