BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17159561 · Received June 19, 2023

    Report

    Report Number
    1213809-2023-00653
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 28, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JUN-2023. H6: INVESTIGATION SUMMARY. (B)(4) SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. FORTY-FOUR SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. ELEVEN SAMPLES DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2025239. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURE OF BATCH 2025239. DURING THE HISTORY REVIEW, ONE LOT WAS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE.

    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: "THE SAFETY GLIDE 25 GAUGE 1 IN NEEDLES FROM BD WILL NOT ALLOW ANY LIQUIDS THROUGH. ONCE WE DRAW UP THE MEDICATION LIKE VITAMIN B12 AND SWITCH THE NEEDLE TO THE 25G 1IN SAFETY GLIDE FROM BD ( REF 305916 LOT 2025239) IT WILL NOT ALLOW THE MEDICATION TO GO THROUGH THE NEEDLE.

    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: "THE SAFETY GLIDE 25 GAUGE 1 IN NEEDLES FROM BD WILL NOT ALLOW ANY LIQUIDS THROUGH. ONCE WE DRAW UP THE MEDICATION LIKE VITAMIN B12 AND SWITCH THE NEEDLE TO THE 25G 1IN SAFETY GLIDE FROM BD ( REF (B)(4) LOT 2025239) IT WILL NOT ALLOW THE MEDICATION TO GO THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191904 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 2025239 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown