BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 8348647 · Received February 18, 2019

    Report

    Report Number
    3002682307-2019-00151
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 22, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2104 (APRIL 15-18TH, 2018) DURING WHICH 69 VISUAL INSPECTIONS WERE CARRIED OUT WITH 0 DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE Nº4411 AND COMES FROM TWO BATCHES: #8096923: (APRIL 12-16TH, 2018) DURING WHICH 157 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #8050652: (FEBRUARY 19-20TH, 2018) DURING WHICH 21 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCHES: #8011733, #7298435 AND #8026641. BD HAS BEEN PROVIDED WITH 1 PICTURE OF LOT 180312 AND RECEIVED AN AFFECTED SAMPLE WHICH SHOW AN EXTRA CANNULA TRAPPED BETWEEN HUB AND SHIELD AND STACKED WITH SOME RESIDUE OF EPOXY IN ONE EDGE (ADHESIVE USED TO JOIN METAL PART WITH PLASTIC YELLOW PART). ALTHOUGH DHR REVIEW NO SHOW EVIDENCE OF REPORTED ISSUE, BASED ON OUR EXPERIENCE EXTRA CANNULA IS PRODUCED DURING THE CANNULA ASSEMBLING PROCESS WHERE THE INSERTION OF THE CANNULA TAKES PLACE USING A ROTARY FEEDER WHICH PLACES EVERY CANNULA INTO THE HUB. AS A RESULT OF SOME ISOLATED PROBLEM, LIKE A JAM, DURING THE INSERTION, SOME CANNULA COULD BECOME DETACHED AND FALL ON THE FOLLOWING NEEDLE (THE AFFECTED ONE). ONCE THE EPOXY IS USED TO JOIN THE CANNULA WITH THE HUB, THE CANNULA REMAINED STUCK ON THE EPOXY AND THIS WAS FINALLY PACKED IN THE UNIT PACK. BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, THE PROBABILITY OF OCCURRENCE OF THIS NON-CONFORMANCE SHOULD BE VERY LOW AND ALWAYS, IN SPORADIC CASES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH AN EXTRA NEEDLE BESIDES THE CANNULA CAP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH AN EXTRA NEEDLE BESIDES THE CANNULA CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139950 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other