BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 9035245 · Received September 13, 2019

    Report

    Report Number
    3002682307-2019-00504
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 20, 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
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 COMPLAINT TRENDING REVIEW SHOW THIS IS THE FIRST TIME THIS LOT IS COMPLAINED. BD HAS 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 2103 (16TH ¿ 19TH FEBRUARY 2019) DURING WHICH 55 VISUAL INSPECTIONS WERE CARRIED OUT WITH 0 REJECTION NOTED. NEEDLES WERE ASSEMBLED IN MACHINE 4407 AND COME FROM TWO DIFFERENT BATCHES: 9049929: (19TH - 22ND FEBRUARY 2019) DURING WHICH 161 VISUAL INSPECTIONS OF (B)(4) UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. 9042949: (12TH ¿ 19TH FEBRUARY 2019) DURING WHICH 297 VISUAL INSPECTIONS OF (B)(4) UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCHES: #8318698 #8299764. BD HAS BEEN PROVIDED WITH ONE PACKED SAMPLE OF LOT: 190217 AND 1 SAMPLE IN AN OPENED PACK OF LOT: 190217 ASSEMBLED INTO A 3 PIECES 3ML SYRINGE. EXAMINATION OF AFFECTED NEEDLE SHOW A CANNULA TOTALLY DETACHED FROM HUB WITH VERY FEW RESIDUE OF EPOXY ON CANNULA NOT IN HUB (ADHESIVE USED TO JOIN CANNULA ¿ METAL PART- WITH HUB ¿PINK PLASTIC PART). PACKED SAMPLE WAS ALSO EXAMINE SHOWING A CORRECT DOSE OF EPOXY AND NO DEFECTIVE NEEDLE. BASED ON RETURNED SAMPLE, AND AFTER REVIEWING THE MANUFACTURING RECORDS, BD CAN CONFIRM THAT THE CANNULA DETACHED FROM THE HUB BECAUSE AN INAPPROPRIATE DOSAGE OF EPOXY (ADHESIVE USE TO JOIN HUB -PLASTIC PART- WITH CANNULA -METAL PART-). THIS COULD HAPPEN DURING THE CANNULA ASSEMBLY PROCESS BECAUSE OF ANY EPOXY ISSUE LIKE INCORRECT DOSAGE, AN EPOXY NOZZLE ADJUSTMENT OR REPLACEMENT. THE NEEDLES ARE 100% INSPECTED FOR PRESENCE OF EPOXY IN THE MANUFACTURING PROCESS, REJECTING ANY NEEDLE WITH ABSENCE OR IMPROPER AMOUNT OF ADHESIVE. IN ADDITION, THIS CAMERA SYSTEM IS CHALLENGED EVERY 8 WORKING HOURS AT THE BEGINNING OF EVERY SHIFT. THEREFORE, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CERTAIN THAT THE PROBABILITY OF OCCURRENCE OF THIS NON-CONFORMANCE IS REALLY LOW AND THIS SHOULD CORRESPOND TO A VERY ISOLATED CASE. MOREOVER, CANNULA PULL OUT TEST IS TESTED IN A ROUTINELY AS PART OF THE IN-PROCESS CONTROL PLAN DURING MANUFACTURING AND BHR REVIEW CONFIRMED H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ NEEDLE WAS FOUND BROKEN INSIDE THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE CAME BROKEN IN THE PACKAGING. NOT USED".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICROLANCE¿ NEEDLE WAS FOUND BROKEN INSIDE THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE CAME BROKEN IN THE PACKAGING. NOT USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826329 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other