BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D ORAL SYRINGE

    MDR report key: 2756199 · Received September 19, 2012

    Report

    Report Number
    MW5027005
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Report Date
    July 13, 2012
    Manufacturer
    B-D
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I AM RAISING THIS SAFETY CONCERN REGARDING B-D ORAL SYRINGES. B-ORAL SYRINGES HAVE HAD WHITE CAPS FOR TIP PLACEMENT AS A SEAL OF THE SYRINGE. THE WHITE CAPS ARE CLEARLY VISIBLE ONCE PLACED UPON THE SYRINGE TIP. CURRENTLY, B-D HAS REPLACED THE WHITE CAPS, CITING IMPROVED SAFETY, WITH AMBER COLOR CAPS. THESE AMBER COLOR CAPS ARE THE SAME COLOR AS THE SYRINGE. UPON PRODUCT EVALUATION AT OUR (B)(6) HOSPITAL, OUR CLINICIANS NOTE A SIGNIFICANT SAFETY CONCERN WITH THE CAPS BEING THE SAME COLOR AS THE SYRINGE ITSELF. OUR NURSE AND PHARMACIST CLINICIANS ARE VERY CONCERNED THAT THE CAP WILL BE OVERLOOKED, GIVEN THE SAME COLOR AND "BLENDING" IN TO THE SYRINGE BARREL, AND WILL NOT BE REMOVED PRIOR TO EXPELLING THE MEDICATION CONTENTS INTO A CUP OR DIRECTLY INTO THE PATIENT'S MOUTH. THIS IS A SIGNIFICANT AND VERY CONCERNING CHOKE HAZARD FOR OUR PEDIATRIC PATIENTS. OBVIOUSLY ALSO CONCERNING TO ADULT AND ELDERLY PATIENTS RECEIVING LIQUID ORAL MEDICATIONS. B-D STATES THAT THEY MADE THIS CHANGE DUE TO WHITE CAPS NOT BEING VISIBLE UPON FLOORS ETC THUS CAUSING A SAFETY CONCERN. WE ARE CONCERNED THAT PROPER DUE DILIGENCE WAS NOT CONDUCTED IN PATIENT SAFETY EVALUATION AND ASSESSMENT FOR MEDICATION ADMINISTRATION. A TYPE OF "LOOK-ALIKE" MEDICATION EVENT POTENTIAL WITH A DIFFERENT SPIN ON IT. PLEASE HELP US VOICE OUR CONCERN AND APPEAL TO OTHER ORGANIZATIONS WHO MAY HAVE SIMILAR CONCERNS. THANK YOU. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: NO. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-D ORAL SYRINGE ORAL SYRINGE KYX B-D

    Patients

    Seq Age Sex Outcome Treatment
    1