BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2874396 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07416
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS REPORT FOR A LEAK AND RUPTURE COULD NOT BE CONFIRMED. THEREFORE A CAUSE WAS NOT IDENTIFIED, BECAUSE A SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE COMPLIANT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THIS ISSUE. A BATCH REVIEW COULD NOT BE PERFORMED AS LOT INFORMATION WAS UNAVAILABLE. IF ANY ADDITIONAL INFORMATION IS AVAILABLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE FIVE CATHETER EXTENSION SETS, WITH LUER ACTIVATION VALVE ADAPTER, WHICH WERE OBSERVED SPLITTING DURING USE. ACCORDING TO THE REPORT, THE CUSTOMER HAD FIVE EXTENSION SETS SPLIT OPEN DURING AN INJECTION RATE OF 2.0PSI. NO SAMPLES ARE AVAILABLE FOR EVALUATION. THERE WAS NO INDICATION OF A PATIENT INJURY OR AN ADVERSE EVENT IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL ADDRESS ONE OF THE FIVE OCCURRENCES CONTAINED IN THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1