BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 10991560 · Received December 11, 2020

    Report

    Report Number
    8041187-2020-00821
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057672
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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 NUMBER 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305767 BATCH NO: 0111881. PRODUCT: BD ECLIPSE INJECTION NEEDLE. NUMBER OF DEFECTIVE PRODUCT(S): 1. WHEN CONNECTED TO SYRINGE NEEDLE SNAPPED OFF.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305767, BATCH NO: 0111881. PRODUCT: BD ECLIPSE INJECTION NEEDLE. NUMBER OF DEFECTIVE PRODUCT(S): 1. WHEN CONNECTED TO SYRINGE NEEDLE SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457935 BD ECLIPSE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0111881 00382903057672

    Patients

    Seq Age Sex Outcome Treatment
    1