BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLES

    MDR report key: 12787911 · Received November 10, 2021

    Report

    Report Number
    3002682307-2021-00603
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    June 8, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210232. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, FIVE NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. FOUR OF THE NEEDLES WERE PACKAGED. ONE OF THE PACKAGED NEEDLES SHOWED NO FOREIGN MATTER. AN UNPACKAGED NEEDLE WAS ALSO RETURNED BY THE CUSTOMER. THE UNPACKAGED NEEDLE HAD EPOXY ALONG THE METAL CANNULA SURFACE. EPOXY IS THE ADHESIVE USED TO JOIN THE CANNULA TO THE PLASTIC HUB. THE EPOXY ON THE CANNULA MOST LIKELY RESULTED FROM A TEMPORARY STOPPAGE OR MALFUNCTION IN THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, A HIGHER AMOUNT OF EPOXY WAS ADDED AND THEN DROPPED ONTO THE AFFECTED CANNULA. BD KEEPS THE PARTICULATE MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. THE ENTIRE ASSEMBLY AND PACKAGING PROCESS TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE STRICTLY FOLLOWED. WE ARE CONFIDENT THESE WERE ISOLATED INCIDENTS WITH AN UNLIKELY RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD MICROLANCE HYPODERMIC NEEDLES HAD EPOXY ON THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: INVESTIGATION FOUND THERE WAS EPOXY ON CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689976 BD MICROLANCE HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown