BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 17998859 · Received October 24, 2023

    Report

    Report Number
    1213809-2023-01173
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 4, 2023
    Report Date
    February 2, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED SOMETHING IS IN THE NEEDLE CAUSING A BLOCKAGE. TO AID IN THE INVESTIGATION, FORTY-SIX SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. FORTY-FIVE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. ONE SAMPLE DID NOT EXPEL THE SOLUTION; THIS NEEDLE IS CLOGGED. 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 2202914. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 2202914 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 NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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 THAT THE BD SAFETYGLIDE NEEDLE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS REPORTED BY THE CUSTOMER: "PLUNGER WOULD NOT GO DOWN ON SYRINGE OF NEEDLE. SEEMS LIKE SOME KIND OF FOREIGN MATERIAL IS IN OR ON THE NEEDLE PREVENTING IT FROM SLIDING." WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? RESISTANCE IN THE PLUNGER WHEN DRAWING UP VACCINES AND PUSHING ON THE PLUNGER TO PRIME THE NEEDLE. THERE IS SOMETHING IN THE NEEDLE CAUSING A BLOCKAGE OF SOME SORT. WE EXAMINED VARIOUS NEEDLES AND FOUND SOME DEBRIS INSIDE THE NEEDLES. WE TESTED SEVERAL NEEDLES AND FOUND MANY HAD THE SAME ISSUE, THEREFORE, WE SET ASIDE ALL 10 BOXES ORDERED SINCE THEY HAD THE SAME LOT NUMBER AND WE DIDN'T KNOW IF ALL 10 BOXES OF NEEDLES WERE DEFECTIVE. WAS THERE ANY PATIENT INVOLVEMENT? NO. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. WHAT WAS THE PATIENT OUTCOME? N/A. WHAT PROCEDURE WAS BEING PERFORMED? DRAWING UP VACCINES AND PRIMING THE NEEDLE. WHAT MEDICATION WAS USED IN THE PROCEDURE? VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922687 BD SAFETYGLIDE NEEDLE SFTYGLD 25X1 RB MCK FMI BECTON DICKINSON MEDICAL SYSTEMS 2202914 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown