BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 EXTENSION SET WITH BIONECTOR

    MDR report key: 3912922 · Received May 14, 2014

    Report

    Report Number
    2245270-2014-00046
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    VYGON MFG
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER CONDUCTING A LIMITED INVESTIGATION INTO THIS CLAIM VYGON CANNOT CONFIRM A QUALITY PROBLEM WITH THIS DEVICE. DUE THE ABSENCE OF THE DEFECTIVE DEVICE FOR VERIFICATION THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. A LOT HISTORY REVIEW WAS PERFORMED. THE QUALITY CONTROL INSPECTION RECORDS REVEAL ZERO NON-CONFORMITIES IDENTIFIED DURING THIS PARTICULAR LOT MANUFACTURED IN FEBRUARY 2014. IN ADDITION, A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED, AND THE RECORDS INDICATE THIS IS THE ONLY COMPLAINT RECEIVED FOR THIS LOT. NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. HOWEVER, VYGON WILL ENTER THIS INTO OUR COMPLAINT LOG AND CONTINUE MONITOR FOR COMPLAINTS AGAINST CMS-808-1.

    Description of Event or Problem · 1

    SET LEAKING FROM WHITE HUB/CLEAR PLASTIC CONNECTION AND A CRACK IN BLUE INSERTION SITE ON WHITE HUB. THE PATIENT OUTCOME WAS EXPOSURE TO MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288122 7 EXTENSION SET WITH BIONECTOR INTRAVASCULAR ADMINISTRATION SET FPA VYGON MFG CMS-808-1 1402017

    Patients

    Seq Age Sex Outcome Treatment
    1