BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15671546 · Received October 25, 2022

    Report

    Report Number
    1213809-2022-00800
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: (B)(6)2022. INVESTIGATION SUMMARY FIFTY TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWENTY SAMPLES WERE RANDOMLY SELECTED FOR EVALUATION. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, CLOGGED NEEDLE WAS NOT CONFIRMED. PREVIOUS INVESTIGATIONS REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2003405. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS BLOCKED WHEN TRYING TO DISPEL AIR THROUGH THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS CUSTOMER IS STILL HAVING PROBLEMS WITH ITEM 309516 FROM LOT # 2003405." "NOT ABLE TO HAVE AIR PUSHED THROUGH THE DEVICE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS BLOCKED WHEN TRYING TO DISPEL AIR THROUGH THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS CUSTOMER IS STILL HAVING PROBLEMS WITH ITEM 309516 FROM LOT # 2003405." "NOT ABLE TO HAVE AIR PUSHED THROUGH THE DEVICE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720086 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2003405 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown