BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17857211 · Received October 2, 2023

    Report

    Report Number
    1213809-2023-01093
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 18, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS NO HOLE IN THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SAFETY MECHANISM HAS BEEN ACTIVATED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION EXPELLED WITH A NORMAL FLOW. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. 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. 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 THE RETURNED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOLE IS MISSING IN THE SAFETY NEEDLE & THE SYRINGE IS UNABLE TO GO PUSH THROUGH.

    Description of Event or Problem · 0

    MATERIAL#: 306616. BATCH#:2202913. IT WAS REPORTED BY CUSTOMER THAT HOLE IS MISSING IN THE SAFETY NEEDLE & THE SYRINGE IS UNABLE TO GO PUSH THROUGH. VERBATIM: HOLE IS MISSING IN THE SAFETY NEEDLE & THE SYRINGE IS UNABLE TO GO PUSH THROUGH. ADDITIONAL INFO FROM CUSTOMER: 26-SEP-2023. 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 DIPUSES 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 (B)(4) BOXES OF THE DEFECTIVE AMOUNT THAT I HAVE PULLED. THANKS. -WHAT IS THE QUANTITY OF PRODUCTS FOUND DEFECTIVE? DEFECTIVE QUANTITY WAS SPORADIC. -PLEASE PROVIDE EVENT DATE. OVER A MONTH TIME SPAN. -IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY OCCURRED? NO. -ARE YOU ABLE TO SEND SAMPLES TO BD FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED? YES, I KEPT A DEFECTIVE ONE ON HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847049 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202913 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown