BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3170106 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15362
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 21, 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). A VISUAL INSPECTION OF THE DEVICE VERIFIED THAT THE TUBE WAS DISCONNECTED FROM THE CHAMBER. UPON CLOSER INSPECTION IT WAS FOUND THAT THE END OF THE TUBING WAS UNDER INSERTED INTO THE CHAMBER. THE CAUSE OF THIS ISSUE WAS RELATED TO A MANUFACTURING PROCESS ISSUE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A DEHP-FREE SOLUTION ADMINISTRATION SET HAD SEPARATED FROM THE DRIP CHAMBER. THIS HAD OCCURRED DURING PRIMING AND THEREFORE THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271757 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12I14V898

    Patients

    Seq Age Sex Outcome Treatment
    1