BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17909176 · Received October 10, 2023

    Report

    Report Number
    1213809-2023-01119
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 13, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 8969359 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLE IS IT WOULD NOT DISPERSE THE VACCINE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306616, LOT 2202913. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2202913 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS THE BEST INFORMATION ON THE DEFECTIVE NEEDLES I CAN GIVE YOU AFTER QUESTIONING MANY OF OUR NURSING STAFF. WHEN OUR NURSES USED THE SAFETY NEEDLE AND IT WOULD NOT WORK THEY WOULD JUST DISPOSE OF IT AND USE ANOTHER ONE. THE PROBLEM WITH THE SAFETY NEEDLE IS IT WOULD NOT DIPURSE THE VACCINE, LIKE THE NEEDLE ITSELF IS DEFECTIVE. I DID KEEP ONE FULLY INTACT FOR INVESTIGATION. ALSO, ON 9/13 WE RECEIVED ANOTHER CASE OF THE LOT THAT IS DEFECTIVE. SO NOW WE HAVE A TOTAL OF 27 BOXES OF THE DEFECTIVE AMOUNT THAT I HAVE PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180208 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202913 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown