BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2163088 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12138
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A COMPANION SAMPLE WAS SENT IN FOR AN EVALUATION. THE SAMPLE WAS DOCKED TO A SOLUTION BAG AND VIAL. THE SAMPLE FUNCTIONED SUCCESSFULLY WITH NO LEAKING ISSUES. THE REPORTED CONDITION WAS NOT CONFIRMED; THE CAUSE OF THIS CONDITION REMAINS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    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 (B)(4) OF A VIAL-MATE RECONSTITUTION DEVICE IN WHICH IT STARTED LEAKING DUE TO THE NEEDLE NOT RETRACTING. THIS CONDITION OCCURRED DURING AN INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR11B22031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MEDICATION, UNKNOWN BAG