BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21881678 · Received April 22, 2025

    Report

    Report Number
    1911916-2025-00297
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 11, 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
    UT, US
    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)(6) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE HUB WHERE THE NEEDLE ATTACHES TO THE SYRINGE WAS CRACKED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. THE NEEDLE HUB HAS A CRACK THAT GOES AROUND ABOUT 80% OF THE HUB DIAMETER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS IF THERE IS A JAM AT THE NEEDLE HUB FEEDER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4212676. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305180 BATCH # 4212676 IT WAS REPORTED BY CUSTOMER THAT "WHEN THE NURSE WENT TO PULL UP A MEDICATION USING A BLUNT FILL NEEDLE THE HUB WHERE THE NEEDLE ATTACHES TO THE SYRINGE WAS CRACKED, AND AS SHE PUNCTURED THE VIAL THE MEDICATION CAME SQUIRTING OUT OF THE CRACK ALL OVER HER." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. PLEASE INCLUDE OUR INTERMOUNTAIN CASE NUMBER, (B)(4), WITH ALL EMAIL COMMUNICATION. SITUATION: WHEN THE NURSE WENT TO PULL UP A MEDICATION USING A BLUNT FILL NEEDLE THE HUB WHERE THE NEEDLE ATTACHES TO THE SYRINGE WAS CRACKED, AND AS SHE PUNCTURED THE VIAL THE MEDICATION CAME SQUIRTING OUT OF THE CRACK ALL OVER HER. BACKGROUND: EVENT OCCURRENCE DATE:(B)(6) 2025 IH #: 93018315 NEEDLE BLUNT FILL 18GAX1.5 MFG #: 305180 SAMPLE AVAILABLE: YES (IF BD WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL, AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 4212676 ASSESSMENT: CREDIT REQUESTED: NO. WAS THEIR INJURY? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742814 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212676 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown