BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 21510391 · Received March 3, 2025

    Report

    Report Number
    2243072-2025-00191
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIAL # 305916 BATCH #(B)(6). IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE HUB HAD A HOLE / WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE HUB WAS FAULTY, NO MED DELIVERED AS VACCINE SPRAYED OUTWARDS VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. TYPE OF INCIDENT/PROBLEM: FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: MINIMAL HARM . AHS OPTIONAL REPORT TO **** (HEALTH CANADA): INCIDENT DETAILS: WRITER ATTEMPTED TO GIVE MENC IN LEFT UPPER ARM, UNFORTUNATELY THE NEEDLE HUB WAS FAULTY, NO MED DELIVERED AS VACCINE SPRAYED OUTWARDS, REATTEMPT AND SUCCESSFUL WITH NEW NEEDLE AND VACCINE IN RIGHT UPPER ARM. WHO WAS AFFECTED? PATIENT. UNEXPECTED OR PROLONGED CARE? YES. PROCEDURE: VACCINATION. DEVICE INFORMATION DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 1 IN. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 305916. SERIAL OR LOT NUMBER: (B)(6). EXPIRY DATE: 2027-09-30. SUPPLIER: **** SUPPLIER/CATALOGUE NUMBER: 308-305916. IS THE DEVICE RETAINED? YES. NUMBER OF DEVICES: 1. WIPED, CONTAINED, LABELLED? FOLLOWED VENDOR¿S SPECIFIC INSTRUCTIONS INVESTIGATION REQUEST. EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW E-MAIL ADDRESS FOR PERSON HOLDING DEVICE:*** CLINICAL CONTACT INFORMATION MANAGER (CC ON FINAL REPORT): ***

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822448 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON REGX0367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown