BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3241510 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19357
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE SAMPLE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION THE SET WAS IDENTIFIED TO BE CUT. THE REPORTED ISSUE WAS IDENTIFIED TO HAVE BEEN CAUSED BY THE PACKING PROCESS. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINU-FLO PRIMARY ADMINISTRATION SET WAS NOTED TO BE BROKEN. THIS WAS OBSERVED INSIDE THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340971 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12F19V680

    Patients

    Seq Age Sex Outcome Treatment
    1