BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK Y-SITE, BULK, STERILE-THIS COMPONENT

    MDR report key: 1820268 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02848
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER FOUND AN "INVERTED SEPTUM" ON THE Y-SITE DURING PRIMING AND REPORTED IT TO THEIR BAXTER (B)(4) SALES REPRESENTATIVE. THE CUSTOMER NOTICED LEAKAGE FROM THE SEPTUM DURING PRIMING WITH SALINE SOLUTION. NOTHING WAS CONNECTED TO THE SEPTUM. THERE WAS NO PATIENT INJURY. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK Y-SITE, BULK, STERILE-THIS COMPONENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE S09E28126R

    Patients

    Seq Age Sex Outcome Treatment
    1