BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3172419 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15507
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE NOTED NO ABNORMALITIES. FUNCTIONAL TESTING WAS PERFORMED AND A LEAK WAS IDENTIFIED BETWEEN THE TUBING AND THE LOWER Y-SITE. THE CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADMINISTRATION SET LEAKED FROM A HOLE IN TUBING NEAR THE INJECTION SITE DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272847 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12K30V612

    Patients

    Seq Age Sex Outcome Treatment
    1