BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP CHAN DRN SIL RND 10FR FULL W/TRO

    MDR report key: 15279357 · Received August 23, 2022

    Report

    Report Number
    1423537-2022-00822
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    January 1, 1980
    Report Date
    December 15, 2022
    Manufacturer
    NINGBO LUKE MEDICAL DEVICES CO., LTD
    Product Code
    KGZ
    UDI-DI
    20885380182423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CANNOT CONFIRM THE ACTUAL COMPLAINT LOT NUMBER. SUPPLIER REVIEWED DEVICE HISTORY RECORD (DHR) FROM THE LAST FIVE MONTHS. THEY FOUND NO ABNORMALITY DURING PRODUCTION AND INSPECTION. NO SAMPLE AVAILABLE FOR INVESTIGATION. THE SUPPLIER TESTED THEIR RETAINED SAMPLES FROM 3 LOT NUMBERS PRODUCED IN THE LAST 5 MONTHS (N210460, N210468 AND N210278). THE TESTS INCLUDE BREAKING STRENGTH TEST AND DRAIN MEASUREMENTS. THE TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. BASED ON THE INVESTIGATION RESULT FOR THE RETAINED SAMPLES, THE PRODUCTS MEET THE PRODUCT SPECIFICATION. THEREFORE, WITHOUT THE COMPLAINT SAMPLE, LOT NUMBER OR ADDITIONAL INFORMATION, THE SUPPLIER IS NOT ABLE TO DETERMINE A ROOT CAUSE FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    MDR SUPPLEMENTAL REPORT BEING FILED DUE TO THE MANUFACTURER NAME AND ADDRESS IN SECTIONS D3, F14, AND G1 ENTERED INCORRECTLY. THE CORRECT INFORMATION IS NOW BEING SUBMITTED. NO OTHER CHANGES TO THE REPORT ARE REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE WOUND DRAINS WERE STIFF AND NOT FLEXIBLE ENOUGH TO MAKE THEM EASY TO WORK WITH. THE CUSTOMER ALSO REPORTED THAT ONE DRAIN BROKE OFF WHEN IT WAS BEING REMOVED FROM THE PATIENT. THE COMPLAINT SAMPLES, PHOTOS AND LOT NUMBERS WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447291 JP CHAN DRN SIL RND 10FR FULL W/TRO ACCESSORIES, CATHETER KGZ NINGBO LUKE MEDICAL DEVICES CO., LTD JP-2187 UNKNOWN 20885380182423

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown