BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 22676259 · Received July 31, 2025

    Report

    Report Number
    1911916-2025-00547
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 18, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    MEG
    UDI-DI
    00382903059041
    PMA / PMN Number
    K992734
    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

    IT WAS REPORTED THAT THE NEEDLE BECAME COMPLETELY DETACHED FROM THE PLASTIC SAFETY COMPONENT. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, FOUR PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGES DEPICT A NEEDLE ASSEMBLY WITH THE SAFETY MECHANISM ENGAGED. THE NEEDLE ITSELF IS SEPARATED FROM THE ASSEMBLY. THE FOURTH PHOTOGRAPH HAS A PACKAGING TOP WEB LABELED CARDINAL HEALTH. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305904, COVERING THE POTENTIAL LOT NUMBERS 2131487 AND 4059264. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE MANUFACTURING OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE REPORTED ISSUE HAS BEEN CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF THE PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305904, BATCH#: 2131487, 4059264, 2131487, 4059264 (POSSIBLE LOTS) . RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT MALFUNCTION/FAILURE MODE: DEFECTIVE COMPONENT PRODUCT DESCRIPTION SUMMARY: I JUST HAD A CONVERSATION WITH XX. DURING AN LP PROCEDURE THIS AM THE DOCTOR WAS USING ONE OF THE SAFETY NEEDLES INCLUDED IN THE KIT WITH LIDOCAINE AND WHILE MOVING THE LIDOCAINE AROUND THE NEEDLE CAME COMPLETELY OFF THE PLASTIC SAFETY PART AND LEFT THE NEEDLE ALONE ATTACHED TO THE PATIENT. CLEARLY THERE WAS A DEFECT WITH THE NEEDLE. MFG. SKU NUMBER: 305904 INVESTIGATED COMPONENT LOT NUMBER: 2131487, 4059264, 2131487, 4059264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197376 BD SAFETYGLIDE SYRINGE, ANTISTICK MEG BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903059041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown