BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1024879-2016-00054

    MDR report key: 6100229 · Received November 14, 2016

    Report

    Report Number
    1024879-2016-00054
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 24, 2016
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FIFTY CUSTOMER RETURNED SAMPLES WERE RETURNED FOR EVALUATION. ALL FIFTY SAMPLES WERE MANUALLY INSPECTED FOR LOOSE IV PROTECTORS WITH NO DEFECTS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT # 6161996 REVEALED THAT THE DEVICE WAS MANUFACTURED IN JUNE, 2016, THERE WERE NO IRREGULARITIES DURING MANUFACTURE. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS UNABLE TO VERIFY THE CUSTOMER'S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A CLINICIAN WAS REMOVING A 21 G X 0.75" BD VACUTAINER ULTRATOUCH" PUSH BUTTON BLOOD COLLECTION SET FROM ITS PACKAGE, THE NEEDLE PROTECTIVE COVER SLID OFF AND SHE STUCK HER FINGER. THE CLINICIAN RECEIVED A DTP BOOSTER.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention