BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2900196 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00420
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 18, 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: TWO HUNDRED COMPANION SAMPLES WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE OBSERVED. FIFTEEN RANDOMLY PICKED SAMPLES WERE TRACTION TESTED. NO DISCONNECTIONS WERE REVEALED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. 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 (B)(4) OF A DEHP FREE SOLUTION ADMINISTRATION SET WITH INJECTION SITE IN WHICH THE SET WAS FOUND LEAKING DUE TO THE TUBING BEING SEPARATED FROM THE LUER LOCK. THE EVENT OCCURRED DURING INFUSION WHEN THE NURSE WAS TRYING TO CONNECT TO A STOPCOCK OR CATHETER. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6641 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12I30V804

    Patients

    Seq Age Sex Outcome Treatment
    1