BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL ECLIPSE 23X1-1/2 RB TW

    MDR report key: 21323664 · Received February 6, 2025

    Report

    Report Number
    2243072-2025-00057
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    October 28, 2024
    Report Date
    February 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903033065
    PMA / PMN Number
    K161170
    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

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL ECLIPSE 23X1-1/2 RB TW SAFETY SHIELD BROKE OFF IT WAS REPORTED BY CUSTOMER THAT THE GUARD OF THE INJECTION NEEDLE BROKEN WHEN IT WAS TO BE APPLIED AFTER THE INJECTION. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT CODE: 303306 PRODUCT DESCRIPTION: SYRINGE & NEEDLE 3CC 23G X 1.5IN L/L RB TW BX/50 LOT/SERIAL #: (B)(6) EXPIRY DATE: 2027-09-30. PROBLEM INFORMATION PRODUCT CONCERN TICKET NUMBER: (B)(4) (DATE OF INCIDENT: (B)(6)2024 CONCERN DESCRIPTION: THE GUARD ON AN INJECTION NEEDLE BROKE WHEN IT WAS TO BE APPLIED AFTER THE INJECTION. THIS DEVICE PROBLEM HAS OCCURED 4 TIMES OVER THE LAST YEAR WITH CLINICAN USER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918026 BD SYRINGE 3ML LL ECLIPSE 23X1-1/2 RB TW SYRINGE FMF BECTON DICKINSON 2289198 00382903033065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown