BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23 G X 0.75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 5841385 · Received August 2, 2016

    Report

    Report Number
    1024879-2016-00032
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 19, 2016
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ALTHOUGH IT WAS INITIALLY REPORTED THAT A SAMPLE WOULD BE RETURNED FOR EVALUATION, A SAMPLE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6132861. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, CAPA (B)(4) HAS BEEN INITIATED WITH REGARDS TO PARTIAL/NO IV NEEDLE RETRACTION AND AN INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 23 G X 0.75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET, AN EMPLOYEE OBTAINED A CONTAMINATED NEEDLE STICK INJURY, POSSIBLY DUE TO A NEEDLE RETRACTION FAILURE OF THE SAFETY DEVICE. THE EMPLOYEE RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492856 23 G X 0.75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6132861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention