BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3930274 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22395
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. ONE FILLED BAG WAS RECEIVED AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED A SMALL HAIR APPROXIMATELY 1 CM IN LENGTH INSIDE THE BAG. THE CAUSE WAS UNDETERMINED. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE AN OXYGEN BARRIER PARENTERAL NUTRITION CONTAINER AFTER COMPOUNDING. THE REPORTER STATED THAT FILTERS HAD BEEN USED ON ALL THE LINES USED TO FILL THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406544 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 13G01V165

    Patients

    Seq Age Sex Outcome Treatment
    1