BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1 1/2 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 6034551 · Received October 17, 2016

    Report

    Report Number
    1213809-2016-00035
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 8, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER A PHOTO OF THE SUSPECT DEVICE WAS. A PHOTO INSPECTION REVEALED THAT THE NEEDLE COVER WAS MISSING AND RESULTED IN AN EXPOSED CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5243638. CONCLUSION: ALTHOUGH THE VISUAL INSPECTION CONFIRMED THE CUSTOMER'S INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER ALSO NOTES THAT THERE ARE TWO ROOT CAUSE SCENARIOS WHICH COULD CAUSE THE ISSUE NOTED: SCENARIO #1 - THE CAUSE COULD BE DURING THE NEEDLE ASSEMBLY PROCESS (BD'S VENDOR). THIS PROCESS IS PERFORMED IN THE BD (B)(4) PLANT AND SHIPPED TO BD (B)(4) AS A FULLY ASSEMBLED NEEDLE WITH SHIELD. SCENARIO #2 -THE CAUSE COULD BE DURING THE NEEDLE PACKAGING PROCESS AT BD (B)(4). DURING THIS PROCESS THE ASSEMBLED NEEDLE IS MOVED THROUGH A VIBRATORY BOWL / RAIL. THIS MOVEMENT OF THE ASSEMBLED NEEDLE COULD CAUSE THE NEEDLE SHIELD TO FALL OFF IF THE SHIELD PULL OFF FORCE IS LOW. CORRECTIVE ACTION: CHANGES WILL BE MADE IN THE FEED SYSTEM FOR THE PACKAGING PROCESS AT BD (B)(4) TO BE ABLE TO DETECT AND PREVENT NEEDLES WITHOUT SHIELD FROM BEING PACKAGED. THESE UN-SHIELDED NEEDLES WOULD BE REMOVED FROM THE PRODUCT FLOW PREVENTING THEM FROM BEING PACKAGED. IMPLEMENTATIONS OF CHANGES ARE EXPECTED BY MARCH 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SECONDARY PACKAGING OPERATIONS OF A 21 G X 1 1/2 IN. BD SAFETYGLIDE¿ NEEDLE, AN OPERATOR OBTAINED NEEDLE STICK INJURY WHILE HANDLING A BLISTER PACKAGE. THE BLISTER PACKAGE CONTAINED AN EXPOSED NEEDLE. IT IS UNKNOWN IF MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686833 21 G X 1 1/2 IN. BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 5243638

    Patients

    Seq Age Sex Outcome Treatment
    1 Other