BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18207801 · Received November 26, 2023

    Report

    Report Number
    1213809-2023-01341
    Event Type
    Malfunction
    Date Received
    November 26, 2023
    Date of Event
    October 27, 2023
    Report Date
    April 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 3152813 AND OTHER EXPIRATION DATE INCLUDES 05/31/2028- H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 06/01/2023.

    Additional Manufacturer Narrative · 0

    (B)(4): FOLLOW UP MDR FOR DEVICE EVALUATION. DURING REVIEW OF THE PROCESSES, IT WAS DETERMINED 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

    MATERIAL #: 305902 . BATCH #: 3152813, 2018060. IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLES WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD ISSUES WITH SAFETY GLIDE NEEDLES. WE HAVE 2 LOT NUMBERS 3152813, 2018060. WHILE PRIMING THE NEEDLE RESISTANCE WAS MET, UNABLE TO PUSH AIR THOUGH NEEDLE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194472 BD SAFETY-LOK SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2018060 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown