BEUDAMED
    FDA Adverse Event Summary report: N

    EXACTAMED® ORAL DISPENSER, 10 ML

    MDR report key: 2901993 · Received January 8, 2013

    Report

    Report Number
    1419106-2012-00021
    Date Received
    January 8, 2013
    Date of Event
    August 17, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BAXA CORPORATION
    Product Code
    KYX
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BAXA EXACTAMED ORAL DISPENSERS ARE DESIGNED FOR SAFER AND MORE ACCURATE DELIVERY OF ORAL MEDICATIONS; PART NUMBER 8510 IS A 10 ML ORAL DISPENSER IN CASE QUANTITIES OF 500. TWOFER NEEDLES ARE DUAL-PURPOSE NEEDLES THAT CAN BE USED FOR BOTH VENTED AND NON-VENTED ADDITIONS AND WITHDRAWALS OF MEDICATIONS. ON (B)(6) 2012, WE RECEIVED ONE TWOFER NEEDLE IN A PLASTIC BAG FROM THE CUSTOMER: SINCE THE NEEDLE WAS RETURNED REMOVED FROM THE PACKAGING, WAS IMPOSSIBLE TO DETERMINE WHEN O.R WHERE THE NEEDLE CAME FROM. A REVIEW OF THE ELECTRONIC DEVICE HISTORY RECORD (EDHR) FOR THE 8510, LOT NUMBER 772628, SHOWS NO UNUSUAL OCCURRENCES REPORTED DURING PRODUCTION; LOTS PACKAGED BEFORE AND AFTER THIS LOT WERE VARIOUS OTHER ORAL DISPENSERS - NO TWOFER NEEDLES WERE PACKAGED IMMEDIATELY BEFORE OR AFTER THIS LOT WAS PACKAGED. HOWEVER, WE ARE WAITING FOR THE PHYSICAL DHRS, WHICH HAVE BEEN SHIPPED TO OFF-SITE STORAGE, TO REVIEW. THE BIL PACKAGING MACHINE IS AN AUTOMATED HIGH SPEED WEIGHT CONTROLLED PACKAGING SYSTEM THAT WEIGHS PRODUCTS AND PACKAGES THEM PER A PRE-DEFINED RECIPE CONTROLLED BY THE HUMAN MACHINE INTERFACE (HMI) AND ACCOMPANYING OPERATING PROCEDURES AND WAS USED TO PACKAGE THE CASE OF 8510S. THE DHR SHOWS THAT A LINE CLEARANCE OF THE BIL PACKAGING MACHINE WAS PERFORMED AS REQUIRED, THE COUNTING SCALES WERE CALIBRATED, THE BIL PACKAGING MACHINE SETUP WAS CONFIRMED, AND STANDARD OPERATING PROCEDURES WERE FOLLOWED THROUGHOUT THE PACKAGING PROCESS FOR THE LOT. WITH ALL PROCEDURES FOLLOWED, IT IS UNLIKELY THAT THE TWOFER NEEDLE WAS INADVERTENTLY PACKAGED IN WITH THE REPORTED LOT OF 8510S. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED AND IT IS UNLIKELY THAT A TWOFER NEEDLE WAS INADVERTENTLY PACKAGED IN WITH ORAL DISPENSERS, WE WILL CONDUCT A THOROUGH REVIEW OF THE PACKAGING PROCESS AND CONTINUE TO MONITOR THIS ISSUE PER BAXTER TREND ANALYSIS PROCEDURES. IF PERTINENT INFORMATION IS DISCOVERED, AN UPDATE OF THIS MDR WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, WE WERE NOTIFIED THAT A LARGE BORE NEEDLE WAS FOUND INSIDE A PACKAGE OF BAXA EXACTAMED 10 ML AMBER DISPENSERS (8510S); NO PATIENT INVOLVEMENT OR OPERATOR INJURY WAS REPORTED. ON (B)(6) 2012, WE BECAME AWARE THAT THE CUSTOMER FILED A MDR WITH THE FDA (REPORT NUMBER (B)(4)). THIS MDR IS BEING FILED PER OUR PROCEDURE TO FILE AN MDR IN RESPONSE TO ANY MEDWATCH REPORTS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9334 EXACTAMED® ORAL DISPENSER, 10 ML 8510 KYX BAXA CORPORATION 8510 772628

    Patients

    Seq Age Sex Outcome Treatment
    1