BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 22055730 · Received May 20, 2025

    Report

    Report Number
    1213809-2025-00340
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903057627
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE 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. 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 THAT THE BD NEEDLE SFTYGLD 23X1 RB SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305902. BATCH #5023870. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY MECHANISM ON THE NEEDLE WOULD NOT ENGAGE AFTER INJECTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED THE BELOW FEEDBACK CONCERNING AN ADVERSE EVENT INVOLVING ITEM 305762. LOT NUMBER IS 5023870. I AM NOT SEEING ANY RECORD OF THIS LOT PRESENTING ANY ISSUES WITHIN OUR SPACE PRIOR. PLEASE ADVISE ON NEXT STEPS AND IF THIS IS THE FIRST YOU'RE HEARING OF THIS WHEN IT COMES TO THIS LOT NUMBER. ¿INJECTED IMMUNIZATION IN CHILD WITH 23GX1" NEEDLE LOT 502387 EXP: 12/31/2029. EXAMINED NEEDLE AND IT WAS ON IMMUNIZATION CORRECTLY AFTER NEEDLE WAS REMOVED FROM RIGHT VENTROLATERALIS, ATTEMPTED TO ENGAGE SAFETY ON NEEDLE WITH THUMB. THE SAFETY WOULD NOT ENGAGE AND PUSHED OFF OF IMMUNIZATION FALLING TO FLOOR. ATTEMPTED TO ENGAGE SAFETY OF NEEDLE WHILE ON THE FLOOR BUT SAFETY WOULD NOT ENGAGE. HAD TO DISPOSE OF IMMEDIATELY IN SHARPS WITHOUT SAFETY ENGAGED.¿ CUSTOMER RESPONDED ON (B)(6). 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 05/01/2025. 2. PROVIDED LOT # 5023870 NUMBER IS NOT MATCHING WITH PROVIDED MATERIAL #305762. PLEASE CHECK AND PROVIDE THE CORRECT LOT NUMBER & MATERIAL NUMBER. THIS IS A 23 G 1" BD SAFETYGLIDE INJECTION NEEDLE LOT# 5023870 EXP 12/31/2029, REF (UNSURE WHAT THIS MEANS BUT I WILL INCLUDE IT) IS (B)(4). 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THERE WAS NO HARM TO THE PATIENT OR EMPLOYEE. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? I'M SORRY I WAS MULTITASKING. THE EVENT DATE WAS 4/29/2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843919 SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5023870 00382903057627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown