BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1882069 · Received October 25, 2010

    Report

    Report Number
    6000001-2010-04476
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 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 FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER REGARDING A SECONDARY MEDICATION SET THAT WOULD NOT FLOW. THE CUSTOMER ALLEGED THAT THE CONTINU-FLO FUNCTION IS NOT WORKING. IT WAS REPORTED THAT THE IV SET-UP WAS CORRECT, BUT WHEN THE SECONDARY LINE WAS ADDED, THE IV FLUID DID NOT FLOW. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT WITH THIS EVENT. NO ADDITIONAL INFORMATION IS 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