BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2900171 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00419
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 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 WITHOUT THE ORIGINAL PACKAGING WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE ELASTOMERIC OF THE NEEDLE BASED Y-SITE WAS FOUND TO BE MISALIGNED. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO A PROBLEM WITH THE MATERIAL ON THE INJECTION SITE PROVIDED BY THE EXTERNAL SUPPLIER. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    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.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED TO BAXTER (B)(4) OF A SOLUTION ADMINISTRATION SET IN WHICH "SET PRESENTED LEAKAGE ON INJECTION SITE" IT IS NOT SPECIFIED WHEN THE EVENT OCCURRED. 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
    8212 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO

    Patients

    Seq Age Sex Outcome Treatment
    1