BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2882374 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07843
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLE WAS RECEIVED FOR EVALUATION AND INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE OBSERVED. AN UNDER WATER PRESSURE TEST AT 8 PSI WAS PERFORMED. THERE WAS AN ABSENCE OF SOLVENT BETWEEN THE TUBING AND INJECTION SITE AND A LEAK WAS OBSERVED. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. ADDITIONAL INFORMATION: THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A SOLUTION SET IN WHICH A LEAK IS OBSERVED AT THE MOLDED Y. THE PROCESS STEP IS NOT SPECIFIED. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1