BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    MDR report key: 20478208 · Received October 17, 2024

    Report

    Report Number
    2243072-2024-01051
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057672
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    MATERIAL# 305767; BATCH# 0052504. IT WAS REPORTED BY CUSTOMER THAT NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. PRODUCT NUMBER - 305767; LOT NUMBER - 0052504.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB SAFETY SHIELD BROKE OFF. IT WAS REPORTED BY CUSTOMER THAT NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. PRODUCT NUMBER - 305767; LOT NUMBER - 0052504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222688 BD NEEDLE ECLIPSE 25X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 0052504 00382903057672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown