BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE 21G X 1.25" BLOOD COLLECTION NEEDLE

    MDR report key: 3854897 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00112
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BD
    Product Code
    JKA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO AN ABUNDANCE OF CAUTION, THIS EVENT WAS DEEMED REPORTABLE AS A RESULT OF A KNOWN (B)(6) SOURCE. IT IS UNKNOWN AT THIS TIME IF THE SAMPLE WILL BE RETURNED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION, (B)(4).

    Description of Event or Problem · 1

    THE SAFETY SHIELD OF THE NEEDLE BROKE WHILE BEING ACTIVATED, RESULTING IN A NEEDLESTICK INJURY TO THE CLINICIAN. THE SOURCE PATIENT IS A (B)(6) PATIENT. THE NURSE AND SOURCE PATIENT UNDERWENT BLOOD SAMPLING FOR (B)(6) AND FOLLOW-UP TESTING WILL BE CONDUCTED AFTER 1, 3 AND 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315135 BD ECLIPSE 21G X 1.25" BLOOD COLLECTION NEEDLE SAMPLE NEEDLE AND COLLECTION SET JKA BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other