BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ORAL¿ 5ML AMBER

    MDR report key: 8460877 · Received March 28, 2019

    Report

    Report Number
    2243072-2019-00589
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.3. DATE OF EVENT: (B)(6) 2019, D.1. MEDICAL DEVICE BRAND NAME: BD SYRINGE ORAL¿ 5ML AMBER, D. 1 MEDICAL DEVICE TYPE: KYW, D.2. COMMON DEVICE NAME: LIQUID MEDICATION DISPENSER, D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT / 06018, D.4 MEDICAL DEVICE CATALOG #: 305208, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.4. DATE RECEIVED BY MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS ¿ CANAAN, CT / 06018. H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED RATIONALE: NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE ORAL¿ 5ML AMBER ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. VERBATIM: THE CONCERN: THESE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. SEVERAL STAFF HAVE REPORTED THAT ONCE A FLUID IS DRAWN UP INTO THE SYRINGE, THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. THIS IS A GENERAL CONCERN ABOUT THE PRODUCTS USABILITY AND THEREFORE NOT LOT SPECIFIC.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED UNSPECIFIED BD ORAL SYRINGES¿ ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. VERBATIM: THE CONCERN: THESE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. SEVERAL STAFF HAVE REPORTED THAT ONCE A FLUID IS DRAWN UP INTO THE SYRINGE, THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. THIS IS A GENERAL CONCERN ABOUT THE PRODUCTS USABILITY AND THEREFORE NOT LOT SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253210 BD SYRINGE ORAL¿ 5ML AMBER LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other