BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2160469 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11682
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. THE SAMPLE WAS FUNCTIONALLY TESTED UNDER WATER AND NO LEAK WAS OBSERVED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THEREFORE, NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED.

    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

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF FLUID LEAKING FROM THE BLUE AIR VENT SITE OF THE VENTED PACLITAXEL SET WHILE PRIMING WITH SODIUM CHLORIDE. THERE WAS NO INJURY REPORTED ASSOCIATED TO THIS ISSUE. 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 10G17V097M

    Patients

    Seq Age Sex Outcome Treatment
    1