BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3092870 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11307
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE TUBING WAS ATTACHED TO THE INLET PORT OF THE MALE LUER. THE TUBING WAS MANUALLY SEPARATED FROM THE INLET PORT OF THE MALE LUER WHEN PULL TESTED. FURTHER VISUAL EXAMINATION NOTED THAT THERE WAS NO VISIBLE SOLVENT ON THE PLOW RIDGE. THE REMAINING SOLVENT BONDS WERE THEN PULL TESTED, WITH NO FURTHER SEPARATIONS NOTED. THE ROOT CAUSE OF THIS CONDITION WAS NOT DETERMINED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD SEPARATED. THIS OCCURRED PRIOR TO USE, THE CLEARLINK LUER ON THE Y-SITE AT THE DISTAL END OF THE TUBING HAD SEPARATED FROM THE TUBING. THERE WAS NOT PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195117 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13A23047

    Patients

    Seq Age Sex Outcome Treatment
    1