BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 24617514 · Received March 17, 2026

    Report

    Report Number
    1213809-2026-00124
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 13, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096237
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - NEEDLE PULLED OUT OF HUB. 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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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

    B3. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT#: (B)(4). PRODUCT: BD 1ML TB SYRINGE SLIP TIP WITH DETACHABLE PRECISION GLIDE NEEDLE. PRODUCT #: UNKNOWN. LOT NUMBER#: 5120593. COMPLAINT: A REGISTERED NURSE REPORTED VIA EMAIL THAT A BD 1ML TB SYRINGE SLIP TIP WITH BD PRECISION GLIDE NEEDLE DETACHED FROM SYRINGE WHEN USED FOR INTRADERMAL INJECTION LEAVING NEEDLE ON PATIENT'S SKIN. POST MARKET SURVIELLANCE SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484743 SAFETYGLIDE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5120593 00382903096237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other