BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 21X1-1/2 RB TW

    MDR report key: 9385272 · Received November 27, 2019

    Report

    Report Number
    8041187-2019-00960
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057659
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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

    MATERIAL NO.: 305765, BATCH NO.: 8052419. 1 OF 2. IT WAS REPORTED THAT THE NEEDLE ECLIPSE 21X1-1/2 RB TW THE SAFETY DEVICE FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TWO SAMPLES IN MY OFFICE WHERE THE SAFETY DEVICE HAS FALLEN OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 305765, BATCH NO.: 8052419. 1 OF 2. IT WAS REPORTED THAT THE NEEDLE ECLIPSE 21X1-1/2 RB TW THE SAFETY DEVICE FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TWO SAMPLES IN MY OFFICE WHERE THE SAFETY DEVICE HAS FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182310 NEEDLE ECLIPSE 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8052419 30382903057659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other