BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 7110943 · Received December 12, 2017

    Report

    Report Number
    3002682307-2017-00113
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    RESULTS - BD RECEIVED A PICTURE OF SAMPLE BUT IT WAS NOT CLEAR ENOUGH TO CONFIRM THE DEFECT: IT SEEMS A BLACK SPOT ON SHIELD. VISUAL EXAMINATION OF RETURNED SAMPLE REVEAL A BLACK PARTICLE ON CANNULA SURFACE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7163026. CONCLUSION - BASED ON ABOVE RESULTS AND SINCE REVIEW OF PRODUCT HISTORY, WHICH SHOWED NO INDICATION OF THE ALLEGED DEFECT, AND AFTER TALK WITH TECHNICIANS IN CHARGE OF LINES, THE IDENTIFIED PARTICLE MAY BE PROBABLY SOME RESIDUE OF AUXILIARY COMPONENT OF THE ASSEMBLY MACHINE WHICH DROPPED OFF IN CANNULA. BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF OCCURRENCE SHOULD BE EXCEPTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD MICROLANCE¿ NEEDLE WAS FOUND WITH BLACK FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886600 BD MICROLANCE¿ NEEDLE SAFETY SYRINGE W/NEEDLE FMF BECTON DICKINSON, S.A. 7163026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other