BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE 30G X 0.5"

    MDR report key: 9820104 · Received March 11, 2020

    Report

    Report Number
    3002682307-2020-00093
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 13, 2020
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD WAS NOT PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOT 180319 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD UNDERSTANDS A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE DUE TO DEFECTIVE LUER DIMENSIONS OR ANY DAMAGED IN THE SYRINGE TIP. IT COULD ALSO BE RELATED WITH THE HANDLING OF THE PRODUCT AS SOME INSUFFICIENT ADJUSTMENT BETWEEN OF THE DEVICES BY THE END USER. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE PULL OUT OCCURRED DURING USE WITH A BD MICROLANCE¿ 3 NEEDLE 30G X 0.5". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT APPEARS THAT THE MECHANISM WHICH IS THERE TO HOLD THE NEEDLE IN PLACE IS NO LONGER THERE. THE RESULT OF THIS IS THAT THERE IS A SPLIT WHEN ADMINISTERING THE INJECTION NOW."

    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 NEEDLE PULL OUT OCCURRED DURING USE WITH A BD MICROLANCE¿ 3 NEEDLE 30G X 0.5". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT APPEARS THAT THE MECHANISM WHICH IS THERE TO HOLD THE NEEDLE IN PLACE IS NO LONGER THERE. THE RESULT OF THIS IS THAT THERE IS A SPLIT WHEN ADMINISTERING THE INJECTION NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285155 BD MICROLANCE¿ 3 NEEDLE 30G X 0.5" HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other