BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 5792134 · Received July 13, 2016

    Report

    Report Number
    8041187-2016-00048
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    July 6, 2016
    Report Date
    August 4, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A PHOTO OF THE DEVICE WAS PROVIDED AND WILL BE EVALUATED AS PART OF A NO SAMPLE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: AS PREVIOUSLY REPORTED, A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF THE USED DEVICE. AN EVALUATION OF THE PHOTO REVEALED THAT THE SAFETY SHIELD WAS PROPERLY ENGAGED OVER THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5232124. A MANUFACTURING REVIEW REVEALED THAT THE REPORTED DEFECT WAS NOT AFFECTED BY PM, CALIBRATION, OR EQUIPMENT. 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) WAS INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A NURSE HAD USED A 18 G X 1 1/2 IN. BD ECLIPSE NEEDLE, SHE RECAPPED IT AND OBTAINED A CONTAMINATED NEEDLE STICK INJURY. BOTH THE NURSE AND SOURCE PATIENT RECEIVED POST EXPOSURE LAB WORK, THE TEST RESULTS WERE NEGATIVE, AND NO PROPHYLAXIS OF ADDITIONAL MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445270 18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5232124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention