BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2920216 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01260
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION, OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND NO DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A VISUAL INSPECTION OF THE SAMPLE DID NOT IDENTIFY ANY DEFECT. A LEAK IN THE SET WAS IDENTIFIED DURING PRESSURE TESTING. HOWEVER, THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER SALES REPRESENTATIVE TO REPORT ONE CLEARLINK CONTINU-FLO W/2 PORTMANIFOLD - 10DPM NV SET IN WHICH A LEAK WAS OBSERVED "AT THE SPIKE AREA". ACCORDING TO THE REPORT, THE CUSTOMER STATED THAT THERE WAS NO PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26005 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12I19023

    Patients

    Seq Age Sex Outcome Treatment
    1 0.9 SODIUM CHLORIDE