BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 9255478 · Received October 30, 2019

    Report

    Report Number
    3002682307-2019-00577
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG #: 304000 LOT #: 150718 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DHR SHOW NO ABNORMALITIES OR ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE HAD DIFFICULTY DRAWING UP EYLEA DURING USE, AND ADJUSTING THE LIQUID LEVEL IN THE SYRINGE CAUSED ALL THE MEDICATION TO LEAK OUT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VERY HARD AND DIFFICULT TO SUCK THE PRODUCT FROM THE VIAL WITH THE SYRINGE AND THE 18G FILTER NEEDLE. FINALLY, THE PRODUCT WAS ENTIRELY INTO THE SYRINGE. THEN, THE NEEDLE HAS BEEN CHANGED TO THE 30G NEEDLE. WHEN THE DOCTOR ADJUST THE LIQUID LEVEL INTO THE SYRINGE, ALL THE PRODUCT WENT OUT THE SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 MICROLANCE¿ 3 NEEDLE HAD DIFFICULTY DRAWING UP EYLEA DURING USE, AND ADJUSTING THE LIQUID LEVEL IN THE SYRINGE CAUSED ALL THE MEDICATION TO LEAK OUT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VERY HARD AND DIFFICULT TO SUCK THE PRODUCT FROM THE VIAL WITH THE SYRINGE AND THE 18G FILTER NEEDLE. FINALLY, THE PRODUCT WAS ENTIRELY INTO THE SYRINGE. THEN, THE NEEDLE HAS BEEN CHANGED TO THE 30G NEEDLE. WHEN THE DOCTOR ADJUST THE LIQUID LEVEL INTO THE SYRINGE, ALL THE PRODUCT WENT OUT THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052578 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 150718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other