BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8610064 · Received May 14, 2019

    Report

    Report Number
    8041187-2019-00371
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. SINCE NO SAMPLES OR PHOTOS DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE COULD BE DETERMINED AND COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE STOPPER SEPARATED FROM THE PLUNGER UPON RETRACTION DURING USE, GETTING STUCK AND PREVENTING MEDICATION FROM BEING DRAWN UP INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLACK RUBBER TIP THAT IS CONNECTED TO THE WHITE PUSHING DEVICE COMES APART IN THE SYRINGE ONCE RETRACTED. THE RUBBER TIP GETS STUCK INSIDE THE SYRINGE, SO MEDICATION CANNOT BE DRAWN UP FROM VIAL."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: FMI. MEDICAL DEVICE TYPE: HYPODERMIC SINGLE LUMEN NEEDLE. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562. PMA / 510(K)#: K161170. 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 THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE STOPPER SEPARATED FROM THE PLUNGER UPON RETRACTION DURING USE, GETTING STUCK AND PREVENTING MEDICATION FROM BEING DRAWN UP INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLACK RUBBER TIP THAT IS CONNECTED TO THE WHITE PUSHING DEVICE COMES APART IN THE SYRINGE ONCE RETRACTED. THE RUBBER TIP GETS STUCK INSIDE THE SYRINGE, SO MEDICATION CANNOT BE DRAWN UP FROM VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403617 BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 8207169 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other