BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP CHAN DRN SIL FLT 7MM FULL W/TRO

    MDR report key: 16969507 · Received May 19, 2023

    Report

    Report Number
    1423537-2023-00939
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Report Date
    May 19, 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 THE SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE SUPPLIER CANNOT CONFIRM THE COMPLAINT PRODUCT IS PRODUCED BY THEM. HOWEVER, SUPPLIER HAD REVIEWED THE LAST 3 LOT NUMBERS SHIPPED, N210368, N210468 AND N220050. NO ABNORMALITY DURING PRODUCTION AND INSPECTION WAS FOUND. A SAMPLE WAS NOT RETURNED FOR EVALUATION. 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

    CUSTOMER REPORTED THAT DURING REMOVAL OF JP DRAIN FROM THE PATIENT, IT BROKE. THIS IS 1 OF 3 EVENTS THAT HAS HAPPENED AT OUR INSTITUTION WITH THE SAME DRAIN. EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852934 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