BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2163055 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12136
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 20, 2011
    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). A SAMPLE WAS NOT SENT IN FOR AN EVALUATION; THEREFORE AN EVALUATION OF THE ACTUAL SAMPLE CANNOT BE PERFORMED. HOWEVER, A PHOTO OF THE ACTUAL SAMPLE WAS EVALUATED; AND THE REPORTED CONDITION OF A BROKEN FILTER WAS CONFIRMED; THE CAUSE OF THIS CONDITION REMAINS UNIDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4).A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED 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

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A PACLITAXEL SET THAT HAD A BROKEN FILTER. THIS CONDITION WAS DISCOVERED BEFORE-USE; THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION INVOVLED. 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 10D01V061

    Patients

    Seq Age Sex Outcome Treatment
    1