BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR

    MDR report key: 1941518 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06359
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED DUE TO THE LOT NUMBER OF THIS DEVICE BEING UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF A CLEARLINK SECONDARY SET THAT HAS A NO FLOW DUE TO AN OCCLUSION. IT WAS UNKNOWN WHEN THIS INCIDENT OCCURRED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1