BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2123844 · Received June 14, 2011

    Report

    Report Number
    6000001-2011-07691
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED NO NON-CONFORMANCES. A SYRINGE WAS ATTACHED TO THE CLEARLINK VALVE AND A BLOCKAGE WAS FOUND ON THE UNIT, THEREFORE THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THIS CONDITION HAS NOT BEEN IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEAR LINK VALVE IN WHICH FLOW WAS RESTRICTED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT BUT 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, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10A31V244

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION