BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 7290724 · Received February 22, 2018

    Report

    Report Number
    3002682307-2018-00034
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 6, 2018
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: PROVIDED PICTURE AND RETURNED SAMPLE CONFIRM THE DEFECT: PRESENCE OF A GREEN PLASTIC PIECE IN THE HUB WHICH WE IDENTIFIED AS A PIN RACK. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE Nº 2101 ((B)(6) 2017) DURING WHICH 70 VISUAL INSPECTIONS OF 100 UNITS EACH WERE CARRIED OUT WITHIN SPEC. RESEARCH FOUND NO ISSUE OR QN IN ASSEMBLED NEEDLE BATCHES: -#7234057 WHICH WERE ASSEMBLED IN MACHINE Nº4411 ((B)(6) 2017) DURING WHICH 421 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. -#7269497 WHICH WERE ASSEMBLED IN MACHINE Nº4412 ((B)(6) 2017) DURING WHICH 31 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. -#7270428 WHICH WERE ASSEMBLED IN MACHINE Nº4412 ((B)(6) 2017) DURING WHICH 214 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE ROOT CAUSE IN ORDER TO MOVE THE PIECES THROUGH THE ASSEMBLING PROCESS, THE NEEDLES ARE LOCATED IN SOME PLASTIC RACKS MADE OF GREEN POLYCARBONATE. BASED ON THE REPORTED ISSUE, OUR OPINION IS THAT ONE OF THESE "RACK PINS" MAY BREAK AS A CONSEQUENCE OF ANY BLOCKAGE IN THE MANUFACTURING PROCESS REMAINING ATTACHED TO THE NEEDLE. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING PROCEDURES, WE ARE CERTAIN THAT THIS HAS BEEN AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER DESCRIBED AS ¿GREEN PLASTIC¿ WAS FOUND IN A BD MICROLANCE¿ HYPODERMIC NEEDLE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131599 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 171003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other