BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1024879-2016-00039

    MDR report key: 5978685 · Received September 26, 2016

    Report

    Report Number
    1024879-2016-00039
    Event Type
    Injury
    Date Received
    September 26, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 3, 2016
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE WAS MANUFACTURED IN JULY, 2016. THERE WERE NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6180578.

    Additional Manufacturer Narrative · 1

    RESULTS: APPROXIMATELY (B)(4) SAMPLES FROM THE SAME LOT # WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF (B)(4) OF THE SAMPLES FOUND NO MISSING IV PROTECTORS. (B)(4) CUSTOMER SAMPLES WERE EVALUATED FOR NON-IV NEEDLE RETRACTION THROUGH MANUALLY ACTIVATING THE BUTTON BY HAND. THERE WERE NO INCIDENTS OF NON-NEEDLE RETRACTION. A REVIEW OF THE DEVICE HISTORY RECORD HAS NOT YET BEEN COMPLETED. CONCLUSION: 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, THIS COMPLAINT IS BEING CONFIRMED FOR NON-NEEDLE RETRACTION AS BD IS AWARE OF COMPLAINTS FOR THIS ISSUE. CAPA (B)(4) HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN FOR COMPLAINTS FOR PARTIAL/NON-IV NEEDLE RETRACTION TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS. ADDITIONALLY, UPON COMPLETION IF THE REVIEW OF THE DEVICE HISTORY RECORD, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET, "FAILED DURING ACTIVATION," AND A PHLEBOTOMIST RECEIVED A CONTAMINATED NEEDLE STICK INJURY. THE SHEATH FAILED TO FULLY COVER THE NEEDLE LEAVING THE TOP PORTION OPEN TO STICK THE EMPLOYEE IN THE FINGER AS SHE WAS DISPOSING OF THE SET INTO THE SHARPS CONTAINER. THE PHLEBOTOMIST RECEIVED POST EXPOSURE LAB WORK FOR (B)(6) AND (B)(6) AND THE TEST RESULTS WERE (B)(6). NO PROPHYLACTIC TREATMENT OR ANY OTHER MEDICAL INTERVENTIONS WERE REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention