BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3250830 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19937
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION IT WAS DETERMINED THAT THIS IS A DUPLICATE SUBMISSION OF (B)(4). ALL ADDITIONAL INFORMATION WILL BE PROVIDED IN REPORT NUMBER 1416980-2013-19863.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A SYRINGE BROKE OFF AND STUCK IN THE FILL PORT OF A BOLUS INFUSOR DEVICE. THIS OCCURRED WHILE FILLING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353822 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12F023

    Patients

    Seq Age Sex Outcome Treatment
    1