BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL

    MDR report key: 12856026 · Received November 22, 2021

    Report

    Report Number
    1911916-2021-01176
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS REPORTED THERE WAS A BLUNT FILL NEEDLE WITH A DEFECT DISCOVERED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AND OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE HAS AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE WHITE EPOXY DRIP OVER ON THE NEEDLE PLASTIC HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT NUMBER 1120211. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR SETTINGS WERE PERFORMED FINDING EVERYTHING SET CORRECTLY, AND PRODUCT FLOW WAS ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED BD NEEDLE FILTER BLUNT FILL HAD EPOXY IN THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE BLUNT FILL NEEDLE DISCOVERED"

    Description of Event or Problem · 0

    IT WAS REPORTED BD NEEDLE FILTER BLUNT FILL HAD EPOXY IN THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE BLUNT FILL NEEDLE DISCOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755400 BD NEEDLE FILTER BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 1120211 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown