BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3093512 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11376
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE SAMPLE WAS PERFORMED AND CONFIRMED THE PRESENCE OF A CUT/SLICE/HOLE ON TUBING. PRESSURE TESTING WAS ALSO PERFORMED AND CONFIRMED THE REPORTED ISSUE. THE CAUSE OF THE ISSUE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-DEHP SOLUTION SET LEAKED DURING PRIMING. IT WAS REPORTED THAT A SECTION OF THE TUBING HAD A SMALL CRACK IN IT. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196678 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1