BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 23139874 · Received September 24, 2025

    Report

    Report Number
    1911916-2025-00659
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A COMPLAINT WAS RECEIVED REGARDING DILUENT SPRAYING FROM THE SIDES OF A SYRINGE. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED NEEDLE SAMPLE AND A SYRINGE LABELED ¿TETRA¿ FROM GSK WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED USING 10X AND 30X MAGNIFICATION. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE NEEDLE SAMPLE WAS ASSEMBLED WITH A BD SYRINGE CONTAINING SALINE SOLUTION, AND NO LEAKAGE OR IRREGULARITIES WERE NOTED DURING THIS INITIAL EVALUATION. THE RETURNED SYRINGE WAS THEN FILLED WITH SALINE SOLUTION AND A NEEDLE WAS ATTACHED. UPON EXPELLING THE SOLUTION, LEAKAGE WAS OBSERVED BETWEEN THE SYRINGE TIP AND THE LUER CONNECTOR. NO LEAKAGE WAS DETECTED AT THE LUER CONNECTOR OR NEEDLE HUB. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305180, LOT 0202361, WAS COMPLETED. NO QUALITY ISSUES WERE IDENTIFIED DURING PRODUCTION THAT COULD BE LINKED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE RETURNED SAMPLE ANALYSIS, THE REPORTED ISSUE WAS CONFIRMED. HOWEVER, THE LEAKAGE WAS NOT ASSOCIATED WITH THE BD NEEDLE, BUT RATHER WITH THE GSK SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 BLUNT FILL HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305180. BATCH#: 0202361. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INCIDENT OR PROBLEM INFORMATION XXX MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6)2025. TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE). LEVEL OF HARM: XXX OPTIONAL REPORT TO XXX (XXX): INCIDENT DETAILS: ABOUT TO INJECT THE DILUENT INTO THE MMRV VACCINE (PRIORIX TETRA) USING A BLUNT FILL NEEDLE AND THE DILUENT SPRAYED OUT FROM THE SIDES OF THE SYRINGE, ONLY A PORTION OF THE DILUENT WENT INTO THE VIAL - SAME DISCARDED. NEEDLE WAS SECURE AND ATTACHED. IMPACT OF INCIDENT: WHO WAS AFFECTED? NO PERSON AFFECTED. UNEXPECTED OR PROLONGED CARE? UNKNOWN. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION: NEEDLE BLUNT FILL TIP 18 GAUGE X 1.5 INCH. MANUFACTURER: XXX. MANUFACTURER CODE/MODEL: 305180. SERIAL OR LOT NUMBER: (B)(6). EXPIRY DATE: SUPPLIER: XXX. SUPPLIER/CATALOGUE NUMBER: (B)(4). IS THE DEVICE RETAINED? YES. NUMBER OF DEVICES: 1. WIPED, CONTAINED, LABELLED? DEVICE WAS CLEAN OR NOT USED. DEVICE HANDLING HAZARDS (WHEN BLANK HAZARDS NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642277 BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 0202361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown