BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1942967 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06453
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 27, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) OF AN UNKNOWN CLEARLINK CONTINU-FLO SET WHICH THE UPPER Y-SITE WILL NOT ALLOW FLOW FROM AN UNKNOWN SECONDARY SET. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SECONDARY SET