BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2781486 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02088
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED ON THE SAMPLE AND FOUND NO ABNORMALITIES. THE SAMPLE WAS ALSO SUBMITTED TO FUNCTIONAL TEST. DURING THE GRAVITY TEST IT WAS FOUND THAT THERE WAS A BLOCKED CHAMBER. IT WAS DETERMINED THAT THE BLOCKED CHAMBER WAS DUE TO DEFECTIVE RAW MATERIAL. THIS MATERIAL IS NOT MANUFACTURED AT THE PLANT; THE EXTERNAL SUPPLIER WAS SENT A COMPLAINT OF NON-CONFORMANCE. THE INVOLVED RAW MATERIAL IS MONITORED BY AN ADDITIONAL EXTRA TESTING DURING THE INCOMING INSPECTIONS. THIS ISSUE WILL BE KEPT UNDER THE TRENDING RECORDS. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY PHARMACIST CONTACTED BAXTER (B)(4) TO REPORT A VENTED PACLITAXEL SET THAT "PRESENTED NO FLOW". THIS EVENT OCCURRED DURING INFUSION. THERE WAS A PATIENT INVOLVED BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 11E07V369

    Patients

    Seq Age Sex Outcome Treatment
    1