BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2855071 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06361
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A LEAK WHILE PRIMING WAS NOT CONFIRMED DURING EVALUATION. A VISUAL INSPECTION FOUND NO ISSUES WITH THE DEVICE. A FUNCTIONAL LEAK TEST WAS PERFORMED WITH NO LEAKS OBSERVED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED TO BAXTER FRANCE OF A DEHP FREE SOLUTION ADMINISTRATION SET W/ INJECTION SITE IN WHICH A LEAK WAS OBSERVED AT THE LEVEL OF THE INJECTION SITE DURING PRIMING OF THE SET WITH NACL 0.9%, 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 - MALTA 12E31V582

    Patients

    Seq Age Sex Outcome Treatment
    1