BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2880506 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07775
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE TUBING OF THE SET WAS FOUND TO BE CUT, WHICH RESULTED IN THE MISSING SPIKE. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE RELATED TO THE SEALING OF THE BLISTER PACKAGING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLO-GARD SOLUTION SET IN WHICH THE SET WAS MISSING THE SPIKE. THE EVENT WAS OBSERVED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. BAXTER QUALITY ENGINEERING DETERMINED THE REPORTED CONDITION TO BE A LEAKS-CUT/SLICE/HOLE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE37L1

    Patients

    Seq Age Sex Outcome Treatment
    1