BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 16109650 · Received January 5, 2023

    Report

    Report Number
    3002682307-2022-00361
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 10-JAN-2023. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220905. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES AND TWO (2) SHELF CARTONS OF PRODUCT WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, A STRIP OF 5 (5) NEEDLES IN EACH SHELF CARTON PRESENTED BLACK SPOTS IN THE BLISTER PACKAGES. IT HAS BEEN DETERMINED THAT THE FOREIGN MATTER WAS MOST LIKELY SOME RESIDUE OF AN AUXILIAR COMPONENT IN THE PACKAGING MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICROLANCE¿ 3 NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRTY NEEDLES, BLACK GRANULES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICROLANCE¿ 3 NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRTY NEEDLES, BLACK GRANULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139646 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown