BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1024879-2016-00018

    MDR report key: 5619586 · Received April 29, 2016

    Report

    Report Number
    1024879-2016-00018
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    April 8, 2016
    Report Date
    June 1, 2016
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6032690. CONCLUSIONS - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AS NO CUSTOMER SAMPLES WERE RECEIVED FOR EVALUATION. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IT IS KNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TECH DREW BLOOD WITH THE SUSPECT DEVICE AND THEN PUSHED THE BUTTON TO ACTIVE THE SAFETY FEATURE. THE NEEDLE DID NOT RETRACT AND WHEN THE TECH PULLED HIS/HER GLOVE OVER THE HAND HOLDING THE DEVICE, A NEEDLE STICK INJURY OCCURRED TO THE FINGER. THE TECH WAS SENT TO EMPLOYEE HEALTH TO REPORT THE INCIDENT AND HAD POST EXPOSURE LAB WORK.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention