BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH BIONECTOR

    MDR report key: 5368143 · Received January 14, 2016

    Report

    Report Number
    2245270-2015-00117
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    November 30, 2015
    Report Date
    June 15, 2017
    Manufacturer
    VYGON MFG
    Product Code
    FPA
    PMA / PMN Number
    K963981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS DEVICE WAS NOT RETURNED, THE DETAILS OF THE COMPLAINT WILL BE PART OF THE COMPLAIN INVESTIGATION. THE RESULTS OF THE THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION BY FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN SUBMITTED TO VYGON (B)(4), WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. AFTER INVESTIGATING THIS CLAIM VYGON SA CANNOT CONFIRM A QUALITY PROBLEM WITH THIS PRODUCT DUE TO THE ABSENCE OF THE DEFECTIVE DEVICE FOR EVALUATION. HOWEVER, THIS FAILURE MODE IS MOST LIKELY DUE TO A MECHANICAL STRESS APPLIED TO THE BIONECTOR IN ASSOCIATION WITH THE USE OF A CHEMICAL SOLUTION. WITHOUT DETAILED INFORMATION INTO THIS COMPLAINT AND WITHOUT KNOWING THE DEVICE CONNECTED TO THE BIONECTOR AND THE CHEMICAL SOLUTION INJECTED, IT IS DIFFICULT TO PERFORM A MORE DETAILED ROOT CAUSE ANALYSIS. A REVIEW OF OUR COMPLAINT DATABASE WAS PERFORMED, IT WAS CONFIRMED THAT THIS IS SECOND COMPLAINT RECEIVED CONCERNING THIS FAILURE MODE. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS WARRANTED AS THE ROOT CAUSE COULD NOT BE CONFIRMED AND THE RATE OF INCIDENCE IS EXTREMELY LOW. HOWEVER, BOTH VYGON (B)(4) AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    BIONECTOR FOUND CRACKED AT THE TOP OF THE VALVE, CAUSING A LEAK.

    Description of Event or Problem · 1

    BIONECTOR FOUND CRACKED AT THE TOP OF THE VALVE, CAUSING A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26496 EXTENSION SET WITH BIONECTOR INTRAVASCULAR EXTENSION SET FPA VYGON MFG CMS-809 1508056D

    Patients

    Seq Age Sex Outcome Treatment
    1