BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2990389 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05312
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE REPORTED DEFECT WAS NOT OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS IN THE PROCESS OF EVALUATION. UPON THE COMPLETION OF THE EVALUATION OR IF ANY RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOWUP MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A SOLUTION ADMINISTRATION SET IN WHICH THE LUER DID NOT TURN AND COULD NOT BE CONNECTED. THIS EVENT HAPPENED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93572 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SE12ED5

    Patients

    Seq Age Sex Outcome Treatment
    1