BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ORAL 10ML AMBER

    MDR report key: 8459506 · Received March 28, 2019

    Report

    Report Number
    2243072-2019-00584
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    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 ADDITIONAL INFORMATION IS AS FOLLOWS: B.3. DATE OF EVENT: (B)(6) 2019, D.1. MEDICAL DEVICE BRAND NAME: SYRINGE ORAL 10ML AMBER, D. 1 MEDICAL DEVICE TYPE: KYW, D.2. COMMON DEVICE NAME: LIQUID MEDICATION DISPENSER, D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS, D.4 MEDICAL DEVICE CATALOG #: 305209, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.2 MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS.

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A SYRINGE ORAL 10ML AMBER HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, MATERIAL NO. 305209. BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. IN LOOKING BACK, IT DOES NOT APPEAR THAT THIS REPORT WAS SUBMITTED TO YOU. I APOLOGIZE FOR THE DELAY. PLEASE SEE THE ATTACHED PRODUCT FEEDBACK FORM FROM THE HOSPITAL, PHARMACY, REGARDING THE NEO MED ORAL AMBER SYRINGES 1, 3, 5, 10, 20 & 60ML , (MF# VARIOUS), (LOT# VARIOUS). 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. H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, AND NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A UNSPECIFIED BD SYRINGE HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, "MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THAT THE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. " HI , IN LOOKING BACK, IT DOES NOT APPEAR THAT THIS REPORT WAS SUBMITTED TO YOU. I APOLOGIZE FOR THE DELAY. PLEASE SEE THE ATTACHED PRODUCT FEEDBACK FORM FROM THE HOSPITAL, PHARMACY, REGARDING THE NEO MED ORAL AMBER SYRINGES 1, 3, 5, 10, 20 & 60ML , (MF# VARIOUS), (LOT# VARIOUS). 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. UPON COMPLETION OF YOUR INVESTIGATION, PLEASE ENSURE THAT A COPY OF THE QA REPORT IS SENT TO . REFERENCE PRODUCT FEEDBACK #15073 IN ALL FOLLOW-UP COMMUNICATION. THANK YOU."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE ORAL 10ML AMBER HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, MATERIAL NO. 305209. BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. IN LOOKING BACK, IT DOES NOT APPEAR THAT THIS REPORT WAS SUBMITTED TO YOU. I APOLOGIZE FOR THE DELAY. PLEASE SEE THE ATTACHED PRODUCT FEEDBACK FORM FROM THE HOSPITAL, PHARMACY, REGARDING THE NEO MED ORAL AMBER SYRINGES 1, 3, 5, 10, 20 & 60ML , (MF# VARIOUS), (LOT# VARIOUS). 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

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UNSPECIFIED BD SYRINGE HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, "MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE SYRINGES ARE DIFFICULT TO ACCURATELY READ ONCE THEY ARE FILLED WITH LIQUID. THE BLACK MARKINGS ARE VERY DIFFICULT TO ACCURATELY READ WHICH HAD LED TO INCORRECT DOSES OF HIGH ALERT MEDICATION BEING DISPENSED. "HI, IN LOOKING BACK, IT DOES NOT APPEAR THAT THIS REPORT WAS SUBMITTED TO YOU. I APOLOGIZE FOR THE DELAY. PLEASE SEE THE ATTACHED PRODUCT FEEDBACK FORM FROM THE HOSPITAL, PHARMACY, REGARDING THE NEO MED ORAL AMBER SYRINGES 1, 3, 5, 10, 20 & 60ML, (MF# VARIOUS), (LOT# VARIOUS). 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. UPON COMPLETION OF YOUR INVESTIGATION, PLEASE ENSURE THAT A COPY OF THE QA REPORT IS SENT TO. REFERENCE PRODUCT FEEDBACK #(B)(4) IN ALL FOLLOW-UP COMMUNICATION. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255680 SYRINGE ORAL 10ML AMBER LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other