BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3151084 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14567
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIP CHAMBER OF A FLOGARD IV SOLUTION ADMINISTRATION SET DID NOT HAVE AN AIR VENT. THIS SET WAS RECEIVED WITHIN AN ORDER INDICATED FOR A VENTED DRIP CHAMBER. THIS ISSUE WAS IDENTIFIED BEFORE USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249849 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 13B28V471

    Patients

    Seq Age Sex Outcome Treatment
    1