BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2936295 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02383
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 9, 2013
    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 NOT AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS AVAILABLE FOR EVALUATION. EVALUATION SUMMARY: ONE SAMPLE IN AN OPEN POUCH WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ROLLER CLAMP WAS SHORT MOLDED AND THE ROLLER WHEEL WAS MISSING. THE REPORTED CONDITION WAS 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 FRANCE OF A DEHP FREE SOL ADMIN SET WITH INJURY SITE IN WHICH THE WHEEL OF ROLLER CLAMP WAS MISSING FROM THE SET. 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
    40559 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12H31V481

    Patients

    Seq Age Sex Outcome Treatment
    1