BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 6877261 · Received September 19, 2017

    Report

    Report Number
    1024879-2017-00162
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW WAS NOT CONDUCTED BECAUSE A LOT NUMBER COULD NOT BE DETERMINED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTH CARE WORKER RECEIVED A SCRATCH WITH A DIRTY NEEDLE, DUE TO THE SAFETY SHIELD BEING MISSING ON THE 21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THERE WAS NO REPORTED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655852 21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other