BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19924130 · Received August 6, 2024

    Report

    Report Number
    2243072-2024-00867
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWENTY SEVEN NEEDLE SAMPLES AND PHOTO RECEIVED FOR INVESTIGATION, NO DEFECTS OR ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE, ALL SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. NO CLOGGED NEEDLE OCCURRED. FURTHERMORE, 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE FOR CLOGGED NEEDLE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL: 305916 BATCH#: REJN0116 IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE NURSES AT COLUMBIA GATEWAY TODAY REPORTED THAT BD NEEDLE LOT NUMBER 4033669 THAT WAS USED TODAY COMPLETELY DETACHED FROM THE PATIENT (REENACTMENT BELOW WITH MYSELF AS THE PATIENT) AFTER GIVING THE PATIENT A VACCINE. ALSO, WITH THE SAME LOT NUMBER HERE AT COLUMBIA GATEWAY, THERE HAS BEEN ISSUES WITH BLOCKAGE, AND PATIENTS BEING RE-INJECTED BECAUSE OF THE BLOCKAGE. THE RN WHO EXPERIENCED THE NEEDLE BEING DETACHED COMPLETELY FROM THE DEVICE AND LEFT IN THE PATIENT¿S ARM HAD TO CAREFULLY USE A GAUZE AND REMOVE THE STUCK NEEDLE IN THE PATIENT¿S ARM. A SIRI WAS PUT IN TODAY FOR THIS PARTICULAR INCIDENT. FOR THE OTHER INCIDENTS WITH THE BD BLOCKAGE WITH THIS LOT NUMBER, I ASKED THE LEAD NURSE TO TALK WITH THE OB/GYN NURSE DOCUMENTING IN THE SIRI PLATFORM. THE LEAD NURSE ALSO HAS REMOVED ALL THE LOT NUMBER BD NEEDLES OUT OF CIRCULATION. NOT SURE IF THIS IS A PROBLEM AT OTHER SITES WITH THIS LOT NUMBER BD SYRINGE. ADDITIONAL INFO: THIS INCIDENT HAPPENED 7/11/2024 WITH THE BD NEEDLE WHICH CAME COMPLETELY DETACHED AFTER ADMINISTRATION. NEEDLE STUCK IN PATIENT¿S ARM. LOT #S (4033669 AND REJN0116). ADDITIONAL INFO: THERE WAS NO NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770858 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON REJN0116 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown