BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19888498 · Received August 1, 2024

    Report

    Report Number
    1213809-2024-00512
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE NEEDLE HUB SAMPLE AND PHOTO WERE INITIALLY RECEIVED AND MISTAKENLY INVESTIGATED UNDER (B)(4); NO ACTUAL NEEDLE WAS RECEIVED. NO FURTHER TESTING WAS PERFORMED FOR CLOGGED NEEDLE AS THE CANNULA WAS NOT RECEIVED. 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. 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.

    Description of Event or Problem · 0

    MATERIAL: 305916, BATCH#: 4033669. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THAT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241616 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4033669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown