BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2781217 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02015
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECT WAS OBSERVED. THE SAMPLE WAS LUER GAUGE TESTED AND THE LUER LOCK WAS FOUND TO BE WITHIN SPECIFICATION. A PULL TEST WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE SAMPLE WAS UNDERWATER PRESSURE TESTED AT 8 PSI AND NO LEAK WAS OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEARLINK SYSTEM SOLUTION SET LUER ACTIVATED VALVE IN WHICH THE SET WAS "LEAKING CYTOTOXCINS AT DISTAL END OF SET WHERE MALE LUER LOCK ADAPTER CONNECTS TO FEMALE BING. BUNG BEIN USED IS CAREFUSION (B)(4)." THE EVENT WAS REPORTED TO HAVE OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12A03099

    Patients

    Seq Age Sex Outcome Treatment
    1 CYTOTOXINS, CAREFUSION (B)(4)