BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ ECLIPSE SYRINGE 3ML LL W/NDL

    MDR report key: 8515458 · Received April 15, 2019

    Report

    Report Number
    8041187-2019-00302
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WERE PERFORMED AND NO QUALITY NOTIFICATION WAS RAISED ON THE SIMILAR REPORTED DEFECT. THE REPORTED DEFECT CANNOT BE CONFIRMED AS NO PHOTO / SAMPLES WERE RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD¿ ECLIPSE SYRINGE 3ML LL W/NDL THE NURSE PUSHED THE BUTTON, BUT DID NOT HEAR A CLICK AND THE NEEDLE WAS STILL EXPOSED RESULTING IN A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE NURSE PUSHED THE BUTTON AND IT NEVER CLICKED; THE NEEDLE WAS STILL EXPOSED RESULTING IN A NEEDLE STICK. REPORTER STATES NURSE DID NOT RECEIVE ANY TYPE OF MEDICAL TREATMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA / 510(K)#: K980987 (SYRINGE); K161170 (NEEDLE). DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT AFTER USE OF THE BD¿ ECLIPSE SYRINGE 3ML LL W/NDL THE NURSE PUSHED THE BUTTON, BUT DID NOT HEAR A CLICK AND THE NEEDLE WAS STILL EXPOSED RESULTING IN A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE NURSE PUSHED THE BUTTON AND IT NEVER CLICKED; THE NEEDLE WAS STILL EXPOSED RESULTING IN A NEEDLE STICK. REPORTER STATES NURSE DID NOT RECEIVE ANY TYPE OF MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307207 BD¿ ECLIPSE SYRINGE 3ML LL W/NDL HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8082063 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other