BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2210569 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18691
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR AN EVALUATION. VISUAL INSPECTION WAS PERFORMED TO THE SAMPLE AND THE MALE LUER INLET ATTACHED TO THE STOPCOCK ASSEMBLY WAS BROKEN OFF THE MALE LUER. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEAR LINK SET IN WHICH AN UNKNOWN BREAKAGE OCCURRED AT AN UNKNOWN POSITION OF A STOPCOCK AND/OR TUBING. THE SPECIFIC CONDITION AND SPECIFIC ALLEGED DEFECT WERE UNCLEAR SINCE THE CUSTOMER DID NOT HAVE THAT MUCH CLINICAL KNOWLEDGE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION REPORTED. THE SAMPLE IS CONTAMINATED WITH BLOOD. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11B25166

    Patients

    Seq Age Sex Outcome Treatment
    1