BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2821372 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04184
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST

    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. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED FROM THE BAG AS SAMPLE WAS CONTAMINATED WITH BLOOD. HOWEVER, NO NON-CONFORMITIES WERE OBSERVED ON THE THREAD. THE NEEDLE WAS DISCONNECTED AND RECONNECTED TO THE LUER WITH NO DIFFICULTIES. NO FURTHER TESTING COULD BE PERFORMED AS SAMPLE WAS CONTAMINATED WITH BLOOD. THE CUSTOMER REPORTED MALFUNCTION WAS NOT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT AN ADMINISTRATION SET FOR BLOOD AND BLOOD DERIVATIVES IN WHICH "THERE WAS A LEAK. [THE SET] WAS ABLE TO MAKE THE CONNECTION, BUT WITH SOME DEGREE OF DIFFICULTY. THE LUER LOCK THREAD WAS DAMAGED". IT WAS REPORTED THAT THE MALFUNCTION OCCURRED DURING INFUSION. THERE WAS A PATIENT INVOLVED, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 12E05V461

    Patients

    Seq Age Sex Outcome Treatment
    1