BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 20838551 · Received December 3, 2024

    Report

    Report Number
    1213809-2024-00912
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 28, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    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

    FIFTY SAMPLES FROM LOT 4190039 AND FIFTY SAMPLES FROM LOT 4201290 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. EACH SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4190039 AND 4201290. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 4190039 AND OTHER EXPIRATION DATE INCLUDES 2029-06-30. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-07-08.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL#:305901, BATCH#:4190039, 4201290. IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. NEEDLE IS NOT SHARP ENOUGH, AND SOMETIMES NEEDLES DOES NOT RELEASE MEDICATION AND THEY HAVE TO PULL OUT AND DO IT AGAIN. SOME ARE NOT ALLOWING TO PENETRATE THE SKIN. ITEM(S): 305901, LOT(S): 4190039 2ND LOT NUMBER: 4201290

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050190 BD SAFETY-LOK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4201290 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown