BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2233713 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22573
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K101385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. THE SAMPLE WAS REMOVED FROM THE PACKAGE AND VISUALLY INSPECTED FOR ANY OBVIOUS DEFECTS. THE FEMALE LUER OF EACH SAMPLE WAS GAUGED. AN IN-HOUSE INTERLINK SOLUTION SET WAS SPIKED INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER. THE SETS WERE PRIMED AND THE MALE LUERS CAPPED OFF WITH THE RETURNED LUER LOCK CAPS. THE MALE LUERS AND CAPS WERE THEN PLACED INTO A SEPARATE 500ML GLASS GRADUATED CYLINDER AND LEFT FOR A PERIOD OF 24 HRS. THE SAME PROCEDURE WAS PERFORMED WITH THE MALE END OF THE CAPS ATTACHED TO A MALE/FEMALE ADAPTER WHICH WAS THEN ATTACHED TO AN EXTENSION SET MALE LUER. THE SAMPLE WAS THEN WATER PRESSURE TESTED AT 45 PSI. THERE WERE NO OBVIOUS VISUAL DEFECTS THAT WERE NOTED. NO LEAKAGE WAS NOTED AFTER THE 24 HOUR LEAK TEST PERIOD AND NO LEAKS WERE FOUND DURING THE 45 PSI WATER PRESSURE TEST. BECAUSE NO ABNORMALITIES OR LEAKS WERE FOUND, THE COMPLAINT WILL NOT BE CONFIRMED AND THE CAUSE OF THE REPORTED CONDITION WAS NOT IDENTIFIED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A DUAL LUER LOCK CAP IN WHICH THERE WAS LEAKING DETECTED WHEN PRODUCT WAS TIGHTENED. IT SEEMED TIGHT, HOWEVER, THE LUER CAN ACTUALLY BE TURNED ANOTHER FULL ROTATION. THE PROCESS STEP IS DURING USE; HOWEVER THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO 17014

    Patients

    Seq Age Sex Outcome Treatment
    1