BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5634036 · Received May 5, 2016

    Report

    Report Number
    8041187-2016-00031
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    April 27, 2016
    Report Date
    May 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SEALED 18G ECLIPSE NEEDLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS INSPECTED TO SEE IF THE SHIELD WAS ALREADY DETACHING FROM THE SYRINGE. NO ABNORMALITIES WERE DETECTED. THE SAMPLE WAS ATTACHED TO A LUER LOCK SYRINGE AND ACTIVATED PER THE IFU AND NO ABNORMALITIES WERE OBSERVED WITH THE SAFETY MECHANISM. THE SAFETY SHIELD DID NOT DISENGAGE FROM THE NEEDLE HUB. IT WAS PROPERLY SECURED TO THE NEEDLE HUB BEFORE AND AFTER ACTIVATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE AND A MANUFACTURING REVIEW REVEALED THAT THE INCIDENT WAS NOT AFFECTED BY PM, CALIBRATION, OR EQUIPMENT FOR THE REPORTED LOT # 5043235. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, CAPA (B)(4) HAS BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    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 AFTER HAVING USED A 18 G X 1 1/2 IN. BD ECLIPSE NEEDLE FOR AN INJECTION, A NURSE PLACED HIS/HER HAND OVER THE NEEDLE SHIELD, THE SHIELD BROKE OFF, AND THE NURSE OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE NURSE RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289891 18 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5043235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention