BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 17456197 · Received August 3, 2023

    Report

    Report Number
    1213809-2023-00812
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 17, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    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.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2003405. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. H.4. DEVICE MANUFACTURE DATE: 03-JAN-2022. D.4. MEDICAL DEVICE LOT #: 2024138. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026 . H.4. DEVICE MANUFACTURE DATE: 24-JAN-2026. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 01-AUG-2023. H.6. INVESTIGATION SUMMARY: THREE SAMPLES FROM LOT 2003405 AND THREE SAMPLES FROM LOT 2024138 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. FIVE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. ONE SAMPLE FROM LOT 2024138 DID NOT EXPEL THE SOLUTION; THIS NEEDLE IS CLOGGED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OF THE BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G EXPERIENCED BLOCKAGE. WITH LOT NUMBERS 2003405 & 2024138. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT BD NEEDLES THAT DO NOT WORK PROPERLY. THE NEEDLES SEEM TO BE BLOCKED, WHEN THEY ARE ATTACHED TO A SYRINGE THEY DON'T ALLOW ANY AIR/MEDICATION THROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OF THE BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G EXPERIENCED BLOCKAGE. WITH LOT NUMBERS 2003405 & 2024138. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT BD NEEDLES THAT DO NOT WORK PROPERLY. THE NEEDLES SEEM TO BE BLOCKED, WHEN THEY ARE ATTACHED TO A SYRINGE THEY DON'T ALLOW ANY AIR/MEDICATION THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722385 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown