BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17950063 · Received October 17, 2023

    Report

    Report Number
    1213809-2023-01144
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    August 8, 2023
    Report Date
    February 7, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E.4. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH# [MW5144842]. H.3. 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

    PR 8840614 - FOLLOW UP MDR FOR DEVICE EVALUATION. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED DURING PRODUCTION. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WAS CLOGGED. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THREE (3) LPNS(LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION -. ADDITIONAL INFO FROM (B)(4) : (20-SEP-2023). SORRY FOR THE DELAY, THE PRACTICE MANAGER WHO PLACED THIS SAFETY ALERT IN OUR SYSTEM IS OUT ON MEDICAL LEAVE. ACCORDING TO THEIR NURSE SUPERVISOR, WHEN MEDICINE WAS DRAWN UP IN THE SYRINGE & NURSE WENT TO ADVANCE THE PLUNGER IT WOULD NOT ADVANCE. THE NEEDLE DID NOT BREAK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90495 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown