BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB

    MDR report key: 9178485 · Received October 11, 2019

    Report

    Report Number
    8041187-2019-00806
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057888
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT.

    Description of Event or Problem · 0

    MATERIAL NO: 305788, BATCH NO: 8302596. IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB THE SYRINGE PLUNGERS ARE HARD TO PUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF SYRINGES IS HARD TO PUSH (STICKING) ITS KEEPS STOPPING AND IT NEEDS TO PUSH HARD.

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K980987(SYRINGE); K161170 (NEEDLE). 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

    MATERIAL NO.: 305788 . BATCH NO.: 8302596. IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB THE SYRINGE PLUNGERS ARE HARD TO PUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF SYRINGES IS HARD TO PUSH (STICKING) ITS KEEPS STOPPING AND IT NEEDS TO PUSH HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977019 BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8302596 30382903057888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other