BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLES

    MDR report key: 10977231 · Received December 9, 2020

    Report

    Report Number
    3002682307-2020-00396
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/4/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 200816. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ELEVEN SHELF CARTONS OF PRODUCT WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. TWENTY NEEDLES FROM THE SHELF CARTONS PROVIDED WERE TESTED WITH A LAB VIAL. THE NEEDLES PENETRATED THE VIAL AT DIFFERENT ANGLES WITH NO DIFFICULTIES. AFTER MICROSCOPIC EXAMINATION, NO PARTICLES OR SIGNS OF STOPPER FRAGMENTATION WERE FOUND IN ANY OF THE SAMPLES TESTED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    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: A PART OF THE VIAL STOPPER MEMBRANE WAS IDENTIFIED INSIDE THE SYRINGE AFTER ASPIRATION OF DRUG. VIAL USED: 20 ML VIAL CARBOCAIN 10MG/ML

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD MICROLANCE¿ 3 NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PART OF THE VIAL STOPPER MEMBRANE WAS IDENTIFIED INSIDE THE SYRINGE AFTER ASPIRATION OF DRUG. VIAL USED: 20 ML VIAL CARBOCAIN 10MG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443174 BD MICROLANCE 3 NEEDLES LANCET FMK BECTON DICKINSON, S.A. 200816

    Patients

    Seq Age Sex Outcome Treatment
    1