BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLNK SYSTEM Y-TYPE CATH SET/MALE LUER LOCK ADAPTER

    MDR report key: 1914867 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05541
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE THAT THE CLEARLINK NON-DEHP Y-TYPE CATHETER EXTENSION SET IS EXTREMELY DIFFICULT TO MOVE THE FLUID THROUGH THE ONE PORT WHEN THEY A FLUSH. THEY CLAIM THIS HAS BEEN GOING ON FOR A COUPLE OF WEEKS. IT HAS BEEN AN ON AGAIN OFF AGAIN BASIS. 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 CLEARLNK SYSTEM Y-TYPE CATH SET/MALE LUER LOCK ADAPTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1