BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 7371221 · Received March 26, 2018

    Report

    Report Number
    3002682307-2018-00074
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 5, 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
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AN INVESTIGATION HAS BEEN COMPLETED WITH A PICTURE AND SAMPLE RETURNED FOR EXAMINATION. THE PICTURE SHOWS A SHORTER CANNULA AS EXPECTED (AROUND 1.5 CM). CANNULA INVERTED WAS DISCARDED AND VERIFIED AN ABSENCE OF BEVEL ON BOTH POINTS. THE EXAMINATION OF THE RETURNED SAMPLE REVEAL AN OD 0.816 MM (WITHIN SPEC 0.800-0.830 MM). AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE FRAGA PLANT IS PROVIDED CANNULAS FROM SISTER BD PLANTS. DHR/BHR REVIEW: ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. NEEDLES (#7193231) WERE ASSEMBLED IN (B)(4) (JULY 12-19TH, 2017) DURING WHICH 304 VISUAL INSPECTIONS OF (B)(4) UNITS WERE CARRIED OUT WITH NO ABNORMALITIES OR ISSUES DETECTED WITH THE REPORTED ONE. CANNULA'S: #7131119 AND #7159441. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE CUSTOMER COMPLAINT ABOUT NEEDLE SHORTER THAN THEY SHOULD BE; IT WAS CONFIRMED THANKS TO RETURNED PICTURE AND SAMPLE. INVESTIGATION CONCLUSION: OUR CANNULA SUPPLIER CONSIDERED THE POINT WAS NOT FORMED DUE TO AN OUT OF SPECIFICATION LENGTH OF THE CUT CANNULA. THIS SITUATION OCCURS WHEN TUBING (METAL PIECE BEFORE FORMED CANNULA) BREAKS DURING AUTO CUTTING OPERATION SINCE THE MACHINE DOES NOT STOP CUTTING THE PART OF THE TUBING THAT IS STILL INSIDE THE CUTTING SET, AND PARTS MAY BE CUT WITH A SHORTER LENGTH THAN THE LOWER SPECIFICATION LIMIT. SEVERAL IMPROVEMENTS HAVE BEEN IMPLEMENTED IN ORDER TO AVOID RECURRENCE OF CUT CANNULA WITH SHORT LENGTH: INSTALLATION OF SENSORS FOR THE AUTO CUTTERS TO DETECT TUBING BREAKAGE ((B)(6) 2017). IMPLEMENTATION OF TUBE WITH DIFFERENT COLOR SPECIFIC FOR AUTO CUTTER SETUP ((B)(6) 2017). REPORTED CANNULA BATCHES WERE PRODUCED BEFORE THIS IMPROVEMENT ((B)(6) 2017). BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY 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. (B)(6). 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 A BD¿ HYPODERMIC NEEDLE WAS IN THE INCORRECT PACKAGING. THE LABEL STATED IT WAS A 21G 40MM RB TW BUT THE NEEDLE IN THE PACKAGE WAS A 21G SHORT 25MM BLUNT NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214889 BD MICROLANCE¿ NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 7192007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other