BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 23080329 · Received September 17, 2025

    Report

    Report Number
    1213809-2025-00607
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. 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. OUR QUALITY 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 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305901 BATCH # 2011009 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): 8741 DATE OF INCIDENT (YYYY-MM-DD): 2025-08-29 SITE NAME/LOCATION: ***** LEVEL OF HARM: AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: NURSE ATTEMPTED TO CONNECT 25G 5/8 NEEDLE TO DILUENT PREFILLED SYRINGE TO RECONSTITUTE VACCINE AND HAD TO PUSH VERY HARD TO ATTACH NEEDLE AND LUER LOCK TWISTED OFF OF SYRINGE., NURSE UNABLE TO PUSH HARD ENOUGH FOR NEEDLE TO ATTACH AND TWO VACCINES NEEDED TO BE WASTED DUE TO LEAKAGE. THIS OCCURRED TWICE IN A ROW AND THEN NURSE HAD TO LOCATE A DIFFERENT VERSION OF 25G 5/8 NEEDLE TO ATTACH AND SUCCESSFULLY ADMINISTER THE VACCINE TO THE CLIENT. IMPACT OF INCIDENT: WHO WAS AFFECTED? NO PERSON AFFECTED FREQUENCY OF PROBLEM: OTHER DEVICE/INCIDENT FACTORS: INVASIVE PROCEDURE? PROCEDURE: IMMUNIZATION- BUT IT WAS DURING THE DRAWING UP OF THE VACCINE PHYSICIAN: DEVICE INFORMATION DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 5/8 IN MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 305901 SERIAL OR LOT NUMBER: 2011009 DEVICE EXPIRY DATE (YYYY-MM-DD): 2025-10-30 SUPPLIER: MEDLINE CANADA CORPORATION SUPPLIER CATALOGUE NUMBER: 308-305901 WAS THE DEVICE RETAINED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577550 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown