BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 8709249 · Received June 18, 2019

    Report

    Report Number
    3002682307-2019-00364
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 2, 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

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOTS 180319 AND 180403 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE AND DETERMINE A DEFINITIVE ROOT CAUSE. SINCE DEFECT IS NOT CONFIRMED AND REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, NO CORRECTIVE ACTION ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE SEPARATED FROM THE BD MICROLANCE¿ 3 NEEDLE WHILE IT WAS IN THE PATIENT'S SKIN. LOT #'S 180319 AND 180403 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "CUSTOMER INFORMED THAT AT THE TIME OF MAKING THE APPLICATION, THE SYRINGE "JUMPED" OUT OF THE NEEDLE. HE WAS ALREADY WITH THE PRODUCT "INSERTED" IN HIS SKIN, THE NEEDLE WAS IN THE SKIN AND THE SYRINGE LEFT. THIS HAPPENED WITH THE FIRST SYRINGE. THEN IT WAS TO MAKE USE OF THE SECOND, AND THE SAME THING HAPPENED. REPORTED THAT HE ALWAYS DOES THE CORRECT HANDLING AND LEAVES THE NEEDLE "TIGHT" IN THE SYRINGE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 180319, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-19. MEDICAL DEVICE LOT #: 180403, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-03-27. (B)(6). 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 SYRINGE SEPARATED FROM THE BD MICROLANCE¿ 3 NEEDLE WHILE IT WAS IN THE PATIENT'S SKIN. LOT #'S 180319 AND 180403 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "CUSTOMER INFORMED THAT AT THE TIME OF MAKING THE APPLICATION, THE SYRINGE "JUMPED" OUT OF THE NEEDLE. HE WAS ALREADY WITH THE PRODUCT "INSERTED" IN HIS SKIN, THE NEEDLE WAS IN THE SKIN AND THE SYRINGE LEFT. THIS HAPPENED WITH THE FIRST SYRINGE. THEN IT WAS TO MAKE USE OF THE SECOND, AND THE SAME THING HAPPENED. REPORTED THAT HE ALWAYS DOES THE CORRECT HANDLING AND LEAVES THE NEEDLE "TIGHT" IN THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503907 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other