BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 5857047 · Received August 9, 2016

    Report

    Report Number
    1416980-2016-13914
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SET, ADMINISTRATION, INTRAVASCULAR
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED SOMETIME IN (B)(6) 2016. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN UNDERINFUSION WITH A ONE LINK SET. THE ONE LINK HAD TO BE REMOVED AND THE SET CONNECTED DIRECTLY TO THE HUB. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513988 NI SET, ADMINISTRATION, INTRAVASCULAR FPA SET, ADMINISTRATION, INTRAVASCULAR NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1