BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2855033 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06354
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 9, 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: ONE SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBE WAS DISCONNECTED FROM THE CHAMBER DUE TO LOW INSERTION. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO LOW INSERTION. 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 (B)(4) OF A DEHP FREE SOL ADMIN SET IN WHICH THE TUBE OF THE SET WAS FOUND DISCONNECTED FROM THE CHAMBER UPON OPENING OF THE PACKAGE BY A NURSE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12H31V644

    Patients

    Seq Age Sex Outcome Treatment
    1