BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950532 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03302
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. 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. IF ADDITIONAL RELEVANT INFORMATION, OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A DEHP FREE SOL ADMIN SET WITH INJ SITE IN WHICH THE TUBING CAME AWAY FROM THE LUER LOCK ON THE SET, WHEN TRYING TO REMOVE THE SET FROM THE PATIENT. THE EVENT OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. THE FACILITY HAS SINCE TESTED A COUPLE OF OTHER SETS WITHOUT ANY PROBLEMS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54868 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12I30V803

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE / HARTMANS SOLUTIONS UNKNOWN STRENGTH