BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3851708 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18017
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL AND MICROSCOPIC INSPECTION IDENTIFIED THAT THE TUBING APPEARED TO BE SMASHED INTO THE LUER ACTIVATED VALVE CLOSEST TO THE MALE LUER ADAPTER'S TUBING. IT APPEARED THAT THERE WAS A SLIGHT HOLE COMING OUT OF THE VALVE. THE SET WAS THEN HOOKED UP TO A SOLUTION BAG TO CHECK FOR FLOW. A DRIP WAS NOTED TO BE COMING OUT OF THE VALVE WHERE THE TUBING WAS IDENTIFIED TO BE SMASHED. UNDERWATER LEAK TESTING ALSO FOUND THAT THERE WAS LEAKAGE AT THE SAME VALVE. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. 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 CONTINU-FLO SOLUTION SET LEAKED DURING INFUSION. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328492 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R14B04069

    Patients

    Seq Age Sex Outcome Treatment
    1