BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ STAINLESS STEEL NEEDLES

    MDR report key: 8970091 · Received September 6, 2019

    Report

    Report Number
    3002682307-2019-00485
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 11, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR SHOW NO ABNORMALITIES OR ISSUES AND NO COMPLAINTS FROM OTHER CUSTOMERS HAVE BEEN RECEIVED. BD HAS NOT BEEN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE¿ STAINLESS STEEL NEEDLES HAD CONNECTIVITY ISSUES. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS GOING TO USE THE PRODUCT AND THE LONG NEEDLE WORKED NORMAL IN THE ATTACHED PART OF THE SYRINGE, BUT THE SMALL NEEDLE DID NOT. WHEN HE INJECTED THE MEDICINE THE NEEDLE RELEASED AND THE WHOLE PRODUCT WAS EMPTIED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROLANCE¿ STAINLESS STEEL NEEDLES HAD CONNECTIVITY ISSUES. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS GOING TO USE THE PRODUCT AND THE LONG NEEDLE WORKED NORMAL IN THE ATTACHED PART OF THE SYRINGE, BUT THE SMALL NEEDLE DID NOT. WHEN HE INJECTED THE MEDICINE THE NEEDLE RELEASED AND THE WHOLE PRODUCT WAS EMPTIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765072 BD MICROLANCE¿ STAINLESS STEEL NEEDLES NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other