BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITA JET LIGHT CATHETER SYSTEM

    MDR report key: 1351455 · Received March 24, 2009

    Report

    Report Number
    2032582-2009-00003
    Event Type
    Injury
    Date Received
    March 24, 2009
    Date of Event
    February 6, 2009
    Report Date
    March 21, 2009
    Manufacturer
    CLINICAL PLASTIC PRODUCTS SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PFM MEDICAL IS REPORTING THIS EVENT AS THE DEVICE INVOLVED IS SIMILAR TO DEVICES SOLD BY PFM MEDICAL AND MANUFACTURED AT CLINICAL PLASTIC PRODUCTS DEVICE IN QUESTION WAS MANUFACTURED IN 2008. DEVICE WAS IMPLANTED IN 2009. POST 3 WEEKS OF CYTOSTATIC TREATMENT, THE PT WAS SENT TO HOSPITAL FOR A RED AND NECROTIC SKIN ON THE PORT SITE, REQUIRING SKIN GRAFTING. WE THEREFORE CONFIRM THAT THERE WAS EXTRAVASATION OF CYTOSTATIC PRODUCT. FUNCTIONALITY OF THE DEVICE: WE STUDIED THE FUNCTIONALITY OF THE DEVICE BY INJECTING WATER INTO THE CHAMBER PERMEABILITY COMPLIES WITH THE SPECIFICATION. WE CLAMPED THE TIP OF CATHETER AND INJECTED SOME LIQUID WITH A 10ML SYRINGE. NO LEAKAGE WAS FOUND. THE DEVICE - PORT CHAMBER AND CATHETER DO NOT LEAK. REVIEW OF THE INSTRUCTION FOR USE: THE INSTRUCTIONS INCLUDED WITH EACH DEVICE SPECIFIES IN PAGE 29 THAT "IN THE PROCESS OF ACCESS TO THE CHAMBER, THE USER MUST VERIFY THE CORRECT POSITIONING OF THE NEEDLE BY TAKING A BLOOD SAMPLE" AND CAUTION AGAINST THE SIGN OF EXTRAVASATION OF INFECTION. CONCLUSION: AS THE DEVICE DOES NOT SHOW ANY MANUFACTURING DEFECTS, WE BELIEVE THAT THE CAUSE OF THE INCIDENT IS DUE TO MISPOSITIONING OF THE NON-CORING NEEDLE WHEN ACCESSING THE PORT CHAMBER. SFP 2009.

    Description of Event or Problem · 1

    (AS REPORTED ON VIGILANCE REPORT), PT WAS REFERRED TO THE ONCOLOGY DEPARTMENT OF THE UNIVERSITY HOSPITAL, BECAUSE OF WHAT IS CLEARLY AN EXTRAVASATION OF MITOMYCIN, WHICH IS KNOWN TO MAKE EXTENSIVE NECROSIS IN CASE OF LEAKAGE. THIS PT HAD AN IMPLANTABLE PORT IN WHICH THE SUBSTANCE WAS INJECTED. THIS CHAMBER HAD PREVIOUSLY BEEN IMPLANTED OUTSIDE THE CHUV ON A DATE UNK TO THE CHUV. IN VIEW OF THE WOUND CAUSED BY THE SUBSTANCE, THIS CHAMBER HAS BEEN REMOVED BY A SURGEON FROM THE CHUV. WE DO NOT KNOW IF THE DEVICE WAS DEFECTIVE BUT WE NEED TO ANALYZE IT TO UNDERSTAND THIS SERIOUS INCIDENT AND IF POSSIBLE AVOID REPETITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITA JET LIGHT CATHETER SYSTEM IMPLANTED PORT AND CATHETER SYSTEM LJT CLINICAL PLASTIC PRODUCTS SA 0824 CS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention