BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 18X1-1/2 RB

    MDR report key: 9008991 · Received September 12, 2019

    Report

    Report Number
    8041187-2019-00720
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 28, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057666
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTOS RECEIVED, IT WAS OBSERVED THAT THE SAFETY SHIELD WAS DETACHED FROM THE HUB; THEREFORE THE FAILURE CAN BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THESE BATCHES. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE NEEDLE ECLIPSE 18X1-1/2 RB HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF DETACHING SAFETY MECHANISM BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NEEDLE CAP FALL (PINK).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9078874. MEDICAL DEVICE EXPIRATION DATE: 2024-02-28. DEVICE MANUFACTURE DATE: 2019-03-19. MEDICAL DEVICE LOT #: 9113696. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-19. (B)(6).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE NEEDLE ECLIPSE 18X1-1/2 RB HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF DETACHING SAFETY MECHANISM BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: NEEDLE CAP FALL (PINK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799285 NEEDLE ECLIPSE 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 30382903057666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other