BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2830783 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-05040
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED AND THE PROBLEM WAS CONFIRMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION IDENTIFIED THAT THE SPIKE HAD BROKEN OFF INSIDE THE ADMINISTRATION PORT OF THE SOLUTION BAG, WITH THE BREAK OCCURRING NEAR THE BASE OF THE OF THE SPIKE. THE ROOT CAUSE IS UNDETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDICAL INFORMATION REPRESENTATIVE SENT A COMMUNICATION TO BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A LAV SOLUTION SET THAT HAD THE SPIKE SNAP OFF. THE CUSTOMER HAS STATED THAT THE BREAK HAD OCCURRED DURING SPIKING OF THE BAG, WHEN THE PATIENT WAS NOT CONNECTED TO THE SET. THERE WERE CHEMOTHERAPY SOLUTION BAGS USED (COMPANY UNKNOWN) AND A SODIUM CHLORIDE SOLUTION BAG (BAXTER BAG) USED. THE CUSTOMER STATED THAT THE SPIKE HAD BROKEN IN HALF, WHERE HALF OF THE SPIKE IS IN THE BAG AND HALF ATTACHED TO THE DRIP CHAMBER. THE EVENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12D04067

    Patients

    Seq Age Sex Outcome Treatment
    1