BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SET

    MDR report key: 1863545 · Received October 11, 2010

    Report

    Report Number
    6000001-2010-03829
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE UNIT WAS RECEIVED AT THE PLANT FOR EVALUATION. THE VISUAL INSPECTION DID NOT CONFIRM THE PRESENCE OF ANY PARTICLE INSIDE THE LINE AS IT WAS DESCRIBED BY THE CUSTOMER. THEREFORE, NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS ALSO PERFORMED FOR THE COMPLAINT LOT. THE BATCH REVIEW REPORTS NO MANUFACTURING ABNORMALITIES AND THE LOT WAS DETERMINED TO BE WITHIN MANUFACTURING SPECIFICATIONS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE NOT BEEN RECEIVED FOR THE REPORTED PROBLEM IN THE PREVIOUS SIX MONTHS. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT FOREIGN MATTER WAS OBSERVED IN THE LINE OF A CONTINU-FLO SET. THE DEFECT WAS NOTED PRIOR TO PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 09F24V744

    Patients

    Seq Age Sex Outcome Treatment
    1