BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2830730 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-05026
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 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 WITH THE ORIGINAL PACKAGING WAS AVAILABLE FOR EVALUATION. UPON VISUAL INSPECTION, THE ELASTOMERIC IN THE NEEDLE BASED Y-SITE WAS OBSERVED TO BE MISSING. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A SUPPLIER ISSUE. THE NEEDLE BASED Y-SITE IS NOT MANUFACTURED BY BAXTER, BUT SUPPLIED BY AN EXTERNAL SUPPLIER. ADDITIONAL INFORMATION: 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.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED TO BAXTER (B)(4) THAT AN ADMINISTRATION SOLUTION SET HAD THE "COVER" OF THE NEEDLE BASED Y-SITE MISSING. THE EVENT OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. 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 - SAO PAULO PE37P2

    Patients

    Seq Age Sex Outcome Treatment
    1