BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 30GA 7/8IN BSG W/O SIL W/O SHD

    MDR report key: 21839174 · Received April 15, 2025

    Report

    Report Number
    1911916-2025-00279
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903016643
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). FOLLOW UP: IT WAS REPORTED THERE WAS A HARD PLASTIC BALL COVERING THE TIP OF THE CANNULA. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A METAL PART BENT INTO A CURVE. THE TIP IS ROUNDED AND THERE IS A DROPLET OF A WHITE SUBSTANCE. THE EPOXY CONDITION ON THE NEEDLE OCCURS IF THERE IS A MISFEEDING OF THE CANNULATOR. THE UNIT SHOWN IN THE PHOTO DOES NOT APPEAR TO BE AN ASSEMBLY MANUFACTURED BY THIS BD SITE OR HAS BEEN THROUGH A MANUFACTURING PROCESS BY THE CUSTOMER. THE PHYSICAL SAMPLE WOULD BE REQUIRED TO CONFIRM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301664, POSSIBLE LOT NUMBERS 3256516 AND 3151793. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    MATERIAL # 301664 POTENTIAL BATCH # 3256516, 3151793 IT WAS REPORTED BY THE CUSTOMER THAT A HARD PLASTIC BALL WAS COVERING THE TIP OF THE CANNULA. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. - REPORTED ISSUE SUMMARIZED: IT WAS REPORTED THAT A HARD PLASTIC BALL WAS COVERING THE TIP OF THE CANNULA. - EVALUATION RESULTS: VISUAL INSPECTION WAS FOUND TO BE NON-CONFORMING FOR HAVING EPOXY ON THE TIP OF THE CANNULA. VENDOR: BECTON DICKINSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121959 NEEDLE NS 30GA 7/8IN BSG W/O SIL W/O SHD NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON UNKNOWN 50382903016643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown