BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3033823 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08328
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED THAT THE WHITE ROLLER WAS MISSING FROM THE BLUE ROLLER CLAMP. THE CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL INVESTIGATION CONFIRMED THE REPORTED CONDITION. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN NUMBER OF CLEARLINK CONTINU-FLO SETS WERE RECEIVED WITH THE WHITE ROLLER MISSING FROM THE INSIDE OF THE BLUE ROLLER CLAMP. THIS MALFUNCTION WAS REPORTED TO BE IDENTIFIED BEFORE USE. THERE WAS PATIENT NO INVOLVEMENT; THEREFORE, 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
    136793 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13A10028

    Patients

    Seq Age Sex Outcome Treatment
    1