BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO V-CATH 2 OFR

    MDR report key: 4508109 · Received July 10, 2014

    Report

    Report Number
    3007207906-2014-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 10, 2014
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT (B)(4) WAS ASSESSED TO BE AN MDR BASE ON OUR MDR REPORTING CRITERIA. ADDITIONAL INFORMATION "CLOSURE REPORT" WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN EVALUATED AND A COMPLETED COMPLAINT INVESTIGATION ANALYSIS (QCF-479) HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING PROCEDURE OF INFUSION OF THE SOLUTION THE DISTAL PART OF THE CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405840 NEO V-CATH 2 OFR NEO V-CATH DQY NEO MEDICAL INC. 355-72 1123

    Patients

    Seq Age Sex Outcome Treatment
    1