BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17695472 · Received September 6, 2023

    Report

    Report Number
    1213809-2023-00978
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 23, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-SEP-2023. H.6. INVESTIGATION SUMMARY: TWO HUNDRED NINETY-SIX SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. EIGHTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. SEVENTY-NINE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. ONE SAMPLE DID NOT EXPEL THE SOLUTION; THIS NEEDLE IS CLOGGED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2202913. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 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. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. 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 WHILE USING THE BD SAFETYGLIDE¿ NEEDLE IT IS BLOCKED . THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PRODUCT CONCERN WHEN GIVING THE INJECTIONS WE ARE UNABLE TO PUSH THE MEDICATION OR AIR THROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD SAFETYGLIDE¿ NEEDLE IT IS BLOCKED . THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PRODUCT CONCERN WHEN GIVING THE INJECTIONS WE ARE UNABLE TO PUSH THE MEDICATION OR AIR THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122586 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2202913 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown