BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

    MDR report key: 11312249 · Received February 11, 2021

    Report

    Report Number
    8041187-2021-00090
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 17, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057870
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR EXCEESSIVE SILICONE AFTER WITHDRAWN OF THE PLUNGER. A RING MARK OF SILICONE CAN BE OBSERVED ON THE SYRINGE BARREL SURFACE AND THE SAMPLES WERE THEN SUBJECTED TO THE SILICONE CONTENT DETERMINATION TEST TO DETERMINE THE SILICONE CONTENT. THE SAMPLES PASSED THIS TEST AND THE SILICONE CONTENT WAS WITHIN SPECIFICAITON. THEREFORE, THE TEAM WAS UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAD FOREIGN MATTER ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787, BATCH NO.: 8052067. IT WAS REPORTED THERE WAS OIL ON THE PLUNGER AFTER ADMINISTERING VACCINE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAD FOREIGN MATTER ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787, BATCH NO.: 8052067 . IT WAS REPORTED THERE WAS OIL ON THE PLUNGER AFTER ADMINISTERING VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210422 SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8052067 00382903057870

    Patients

    Seq Age Sex Outcome Treatment
    1