BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE INJECTION PORT AND APP

    MDR report key: 1891252 · Received November 4, 2010

    Report

    Report Number
    3005992282-2010-00345
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 13, 2010
    Report Date
    September 23, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH THE RED SAFETY CAP, LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. NOTE THE CATHETER WAS NOT RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, NO PUNCTURES ON THE INJECTION PORT WERE OBSERVED. A LEAK TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. NO LEAK WAS FOUND. A BLOCKAGE TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. NO BLOCKAGE WAS FOUND. A FUNCTIONAL TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. HOOKS WERE DEPLOYED AND RETRACTED. A CATHETER SAMPLE WAS ATTACHED TO THE SEPTUM RETAINER WITH SUCCESSFUL RESULT. DEVICE WAS RETURNED FULLY FUNCTIONAL. THE COMPLAINT CANNOT BE CONFIRMED THE DEVICE WAS RETURNED FULLY FUNCTIONAL. DURING VISUAL AND FUNCTIONAL INVESTIGATION, IT WAS NOT POSSIBLE TO DUPLICATE THE FEELING OF "LOOSE" OBSERVED BY THE SURGEON. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PORT REPLACEMENT PROCEDURE, THERE WAS LOOSE CONNECTION BETWEEN THE BAND TUBING AND THE PORT CONNECTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE INJECTION PORT AND APP IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ N/A ZLHBD9

    Patients

    Seq Age Sex Outcome Treatment
    1