BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21909690 · Received April 25, 2025

    Report

    Report Number
    1911916-2025-00308
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 1, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. DURING THE RECONSTITUTION OF SOLU-CORTEF, A PIECE OF THE RUBBER STOPPER WAS OBSERVED WITHIN THE SYRINGE BARREL. TO FACILITATE THE INVESTIGATION, OUR QUALITY TEAM RECEIVED ONE NEEDLE SAMPLE WITHOUT A PACKAGING BLISTER AND ONE 10ML SYRINGE FOR EVALUATION. A VISUAL INSPECTION OF THE NEEDLE SAMPLE WAS CONDUCTED USING 30X MAGNIFICATION, REVEALING NO DAMAGE, DEFECTIVE GRIND, OR HOOKS. THE BEVELS AND ETCH WERE FOUND TO BE SATISFACTORY, WITH NO DEFECTS OR IMPERFECTIONS OBSERVED. WITHIN THE SYRINGE, A LIGHT PINK PARTICLE APPROXIMATELY 1/32" IN SIZE WAS IDENTIFIED AT THE BOTTOM. NO ADDITIONAL INFORMATION WAS OBTAINED FROM THIS SAMPLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR MATERIAL NUMBER 305180, LOT 0202361. THE REVIEW DID NOT UNCOVER ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL PROCESSES AND FINAL INSPECTIONS ADHERED TO SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION OF THE RETURNED NEEDLE ASSEMBLY SAMPLE, THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL#: 305180, BATCH#: 0202361. IT WAS REPORTED BY CUSTOMER THAT VISUALISED PIECE OF RUBBER STOPPER IN SYRINGE BARREL DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2025. TYPE OF INCIDENT/PROBLEM: FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE). LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT BEFORE USE. INCIDENT DETAILS: STAFF MEMBER RECONSTITUTING SOLU-CORTEF - VISUALISED PIECE OF RUBBER STOPPER IN SYRINGE BARREL. BROUGHT TO ATTENTION OF WRITER. STAFF MEMBER IDENTIFIED THIS WAS THE SECOND INCIDENT THIS AM WITH THE SAME MEDICATION. UPON REVIEW OF THE PRODUCT MONOGRAPH, NO INDICATION THAT A FILTERED NEEDLE SHOULD BE USED. STAFF MEMBER FOLLOWED ALL INSTRUCTIONS/STEPS TO RECONSTITUTE AND DRAW UP MEDICATION AS OUTLINED IN PRODUCT MONOGRAPH. PROCEDURE: NO. CAPTURED PRIOR TO REACHING PATIENT. 1. THE PROVIDED LOT#: 02072361 WAS NOT FOUND IN OUR RECORDS. COULD YOU PLEASE CHECK AND CONFIRM THE LOT NUMBER? I DON'T HAVE THE WRAPPER FOR THE PRODUCT, ONLY THE PRODUCT ITSELF. OTHERWISE SYRINGE: 4327505; NEEDLE - 0202361. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR THE FIRST INCIDENT? APRIL 01, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325955 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 0202361 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown