BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP CHAN DRN SIL HUBLES 15FR BND TRO

    MDR report key: 15280447 · Received August 23, 2022

    Report

    Report Number
    1423537-2022-00824
    Event Type
    Injury
    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
    20885380182652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS LOT NUMBER WAS NOT PROVIDED. HOWEVER, SUPPLIER HAD REVIEWED DHRS FOR THE LAST FIVE MONTHS. THEY FOUND NO ABNORMALITY DURING PRODUCTION AND INSPECTION FOR THIS PRODUCT. NO SAMPLE WAS AVAILABLE AT THE TIME OF INVESTIGATION. SUPPLIER TESTED THEIR RETAINED SAMPLES FROM TWO LOT NUMBERS PRODUCED OVER THE LAST FIVE MONTHS (N210460 AND N210468). THEIR TESTS INCLUDED SHARPNESS TEST, PATENCY TEST, AND DRAIN MEASUREMENTS. THE TEST RESULTS MEET THE PRODUCTS SPECIFICATIONS. ACCORDING TO THE COMPLAINT INFORMATION THAT THE PATIENT HAD A SEROMA DURING THE OPERATION. SUPPLIER HAD CONSULTED WITH THEIR MEDICAL CONSULTANT ON THIS ISSUE. HOWEVER, THERE ARE MANY CAUSES FOR A SEROMA. BASED THE INFORMATION PROVIDED BY CUSTOMER, IT IS HARD TO DETERMINE THE ROOT CAUSE FOR THIS SEROMA. BASED ON INVESTIGATION, THE SUPPLIER CONCLUDED THAT THEIR PRODUCTS MEET THE PRODUCT SPECIFICATION, AND THEY CANNOT FIND THE ROOT CAUSE OF THIS COMPLAINT. THERE IS NO ACTION TAKEN AT THIS TIME. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS.

    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 PHYSICIANS ARE HAVING ISSUES WITH THE DRAIN THAT IS ATTACHED TO A TROCAR, PASSING THROUGH THE SKIN. THE DRAIN IS STIFF AND HARD TO STRIP. DRAINAGE IS THEN LOW; THE DRAIN IS REMOVED, AND SEROMAS DEVELOP. AN ATTEMPT TO DRAIN THE SEROMA IS NOT ALWAYS SUCCESSFUL. THE PLASTICS GROUP RECENTLY HAD AN INFECTION. SEROMAS AFFECT THE ADHERENCE OF DERMAL TISSUE AND THE PHYSICAL APPEARANCE OF THE RECONSTRUCTIVE SURGERY. NO ADDITIONAL INFORMATION OR PATIENT DEMOGRAPHICS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324695 JP CHAN DRN SIL HUBLES 15FR BND TRO ACCESSORIES, CATHETER KGZ NINGBO LUKE MEDICAL DEVICES CO., LTD JP-2233 UNKNOWN 20885380182652
    2840091 JP CHAN DRN SIL HUBLES 15FR BND TRO ACCESSORIES, CATHETER KGZ NINGBO LUKE MEDICAL DEVICES CO., LTD JP-2233 UNKNOWN 20885380182652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown