BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1781373 · Received August 3, 2010

    Report

    Report Number
    6000001-2010-02207
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED BY BAXTER. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED FOR EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. A BATCH REVIEW WAS PERFORMED. ALL RELEASE CRITERIA WERE ME FOR THE PRODUCTION OF THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD A CUT TUBE AND LEAKAGE WAS OBSERVED. THE EVENT OCCURRED DURING FILLING. THE DEVICE WAS FILLED WITH SODIUM CHLORIDE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLEDAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09K087

    Patients

    Seq Age Sex Outcome Treatment
    1