BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 8750166 · Received July 1, 2019

    Report

    Report Number
    3002682307-2019-00384
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 18, 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 · 1

    INVESTIGATION: SINCE BD WAS UNABLE TO DUPLICATE OR REPRODUCE THE INDICATED FAILURE MODE BECAUSE NO SAMPLE OR PHOTOS HAVE BEEN PROVIDED, A REVIEW OF DHR SHOW NO ABNORMALITIES AND A DEFINITIVE ROOT CAUSE RELATED TO THE NEEDLE MANUFACTURING PROCESS IS NOT POSSIBLE TO DETERMINE AT THIS TIME.

    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 #: 180312, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-15. MEDICAL DEVICE LOT #: 171108, MEDICAL DEVICE EXPIRATION DATE: 2022-10-31, DEVICE MANUFACTURE DATE: 2017-11-08. 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 LEAKAGE OCCURRED WHILE CONNECTING THE BD MICROLANCE¿ 3 NEEDLE TO THE SYRINGE DURING USE. LOT #'S 180312 AND 171108 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING CONNECTING A SYRINGE AND A SMALL NEEDLE, THERE WAS A LEAKAGE"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WHILE CONNECTING THE BD MICROLANCE¿ 3 NEEDLE TO THE SYRINGE DURING USE. LOT #'S 180312 AND 171108 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DURING CONNECTING A SYRINGE AND A SMALL NEEDLE, THERE WAS A LEAKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542643 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other