BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2242593 · Received September 10, 2011

    Report

    Report Number
    6000001-2011-23875
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED AS THE LUER WAS DAMAGED. BASED ON THE SAMPLE'S EVALUATION AND REFERRING TO SIMILAR COMPLAINTS RECEIVED AT THE PLANT FOR THE SAME DEFECT, THE ROOT CAUSE LEADING TO SUCH ISSUE COULD NOT BE LINKED TO THE MANUFACTURING PROCESS AND VISITS PERFORMED AT SOME FRENCH HOSPITALS REVEALED THAT THE REPORTED DEFECT IS PRIMARILY DUE TO PRODUCT MISUSE. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(6) IT IS REPORTED THAT WHEN REMOVING A BAXTER SOLUTION ADMINISTRATION SET (CODE (B)(4) LOT UNKNOWN) THE DISTAL LUER BROKE IN A 3 WAY STOPCOCKS. A PATIENT IS INVOLVED. THERE IS NO CLINICAL CONSEQUENCE REPORTED. THE SAMPLE IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1