BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2894992 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00147
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 12, 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). EVALUATION SUMMARY: ONE SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH 5% GLUCOSE TO TEST FOR THE LEAK. NO LEAK WAS OBSERVED FROM THE LUER LOCK. 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. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF 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 DEHP FREE SOL ADMIN SET IN WHICH THE SET "LEAKED AT THE LEVEL OF THE MALE LUER LOCK DURING THE PREPARATION OF DRUG BAG CHIMIO." THE EVENT OCCURRED DURING PRIMING. 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
    2866 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12H31V636

    Patients

    Seq Age Sex Outcome Treatment
    1