BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML EXACTA MED ORAL LIQUID DISPENSER

    MDR report key: 1719501 · Received April 30, 2010

    Report

    Report Number
    1419106-2010-00007
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    January 15, 2010
    Report Date
    March 31, 2010
    Manufacturer
    BAXA CORP
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY INVESTIGATED AND CORRECTED BY BAXA. THE ROOT CAUSE OF THE INCORRECT TEASPOON DOSAGE MARKINGS WAS DETERMINED TO BE SUPPLIER CAUSED. THE SUPPLIER FOR THESE PARTS WAS ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST AND HAS SINCE COMPLETED CORRECTIVE ACTIONS. A HEALTH HAZARD EVAL WAS COMPLETED FOR THIS TYPE OF FAILURE MODE ON THIS PRODUCT. THE EVAL SHOWED A NEGLIGIBLE RISK OF ADVERSE HEALTH CONSEQUENCES. BAXA HAS NOT RECEIVED ANY REPORTS OF PT INJURY/ILLNESS AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    THE MAUDE DATABASE WAS REVIEWED BY BAXA CORPORATION'S QUALITY DEPARTMENT ON (B)(6) 2009. MEDWATCH (B)(4) WAS DISCOVERED IN REGARDS TO A 5ML ORAL SYRINGE CONTAINING AN ERROR WITH THE TEASPOON MARKINGS. BAXA'S CUSTOMER COMPLAINT SYSTEM WAS REVIEWED AND THE ASSOCIATED COMPLAINT WAS IDENTIFIED. THE CUSTOMER CONTACTED BAXA INSIDE SALES ON (B)(6) 2010 ABOUT THIS FAILURE MODE AND STATED THAT THERE WAS NO PT INVOLVEMENT AND NO OPERATOR INJURY. THE CUSTOMER DID NOT INDICATE THAT THEY INTENDED TO SUBMIT A MEDWATCH AT THE TIME THE COMPLAINT WAS REPORTED. NO PRODUCT WAS RETURNED FOR EVAL. THIS MDR IS BEING FILED PER BAXA CORPORATIONS' PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 ML EXACTA MED ORAL LIQUID DISPENSER 5 ML EXACTA MED ORAL LIQUID DISPENSER LHI BAXA CORP 8505 741826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA