BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ MICROLANCE¿ STAINLESS STEEL NEEDLE

    MDR report key: 7374849 · Received March 27, 2018

    Report

    Report Number
    3002682307-2018-00086
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 23, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RETURNED SAMPLE EVALUATION: EXAMINATION OF RETURNED PACKED SAMPLE OF LOT 160230 SHOWED AN ADDITIONAL CANNULA (METAL PART OF THE NEEDLE) GLUED ON HUB BECAUSE OF SPRINKLED ADHESIVE AND CANNULA TRAPPED BETWEEN THE SHIELD WITH THE BEVEL OUT OF IT. LOT NUMBER / PRODUCT FAMILY HISTORY: COMPLAINT TRENDING REVIEW OF THIS LOT FOR THIS ISSUE REVEALS 1 COMPLAINT (INCLUDING THIS ONE). DHR/BHR REVIEW: "OUR PRODUCTION AND INSPECTION RECORDS OF REPORTED LOT 160230 AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEEDLES WERE PACKED IN MACHINE Nº2101 (FEBRUARY 25-29TH 2016) DURING WHICH 70 VISUAL INSPECTIONS WERE PERFORMED WITH ZERO DEFECTS FOUND. NEEDLES WERE ASSEMBLED IN MACHINE Nº4412 AND COME FROM 2 BATCHES: -#6047358: (FEBRUARY 25-28TH, 2016) DURING WHICH 129 VISUAL INSPECTIONS OF 25 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. -#5173116: (JUNE 22 -JULY 1ST, 2015) DURING WHICH 143 VISUAL INSPECTIONS OF 25 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED." ROOT CAUSE 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 DURING THE INSERTION, SOME CANNULA COULD BECOME DETACHED AND FALLING ON THE FOLLOWING NEEDLE (THE AFFECTED ONE). ONCE THE EPOXY USED TO JOIN THE CANNULA WITH THE HUB WAS CURED IN THE OVEN SYSTEM, THE CANNULA REMAINED STUCK ON THE EPOXY AND THIS WAS FINALLY PACKED IN THE UNIT PACK. THIS SITUATION IS MORE LIKELY IN SMALL GAUGES (LIKE THE REPORTED ONE) DUE TO ITS LOW WEIGHT. 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. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A BD¿ MICROLANCE¿ STAINLESS STEEL NEEDLE WAS SPEARED THROUGH THE SHIELD, POTENTIAL FOR INJURY, AS WELL AS LOSS OF STERILITY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216192 BD¿ MICROLANCE¿ STAINLESS STEEL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 160230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other