BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4162054 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35263
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION FOUND NO ISSUES BUT NOTED THAT THE SET WAS RECEIVED FILLED WITH A VISCOUS SOLUTION. METHYLENE BLUE WAS INTRODUCED FOR GRAVITY TESTING INTO THE DRIP CHAMBER TO MOVE THE VISCOUS LIQUID FROM THE BOTTOM OF THE CHAMBER. THE LIQUID STARTED FLOWING THROUGH THE TUBING; NO BLOCKAGE WAS IDENTIFIED. NO MALFUNCTIONS OR ABNORMALITIES WERE IDENTIFIED DURING THE EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID DID NOT FLOW THROUGH THE TUBING OF A BURETROL IV SOLUTION SET. THIS WAS NOTED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644659 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12E28V359

    Patients

    Seq Age Sex Outcome Treatment
    1