BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SECONDARY MED SET, LUERLOCKAND HANGER NO DISTAL CONNECTOR

    MDR report key: 1943072 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06477
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE AND A REQUEST HAS BEEN MADE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECT WAS OBSERVED. A DELIVERY TEST WAS CONDUCTED USING WATER AND FLUID IS ABLE TO FLOW THROUGH THE SET. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE A CLEARLINK SECONDARY MEDICATION SET WITH AN UPPER Y-SITE NOT ALLOWING FOR BACKPRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL SECONDARY MED SET, LUERLOCKAND HANGER NO DISTAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS PRIMARY SET