BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5727981 · Received June 15, 2016

    Report

    Report Number
    8041187-2016-00038
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 8, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POSSIBLE LOT NUMBERS WERE REPORTED FOR THIS INCIDENT. THE INFORMATION FOR THESE LOT NUMBERS IS AS FOLLOWS: LOT #: 5232198, MEDICAL DEVICE EXPIRATION DATE: 8/31/2020, DEVICE MANUFACTURE DATE: 8/20/2015. LOT #: 5231375, MEDICAL DEVICE EXPIRATION DATE: 8/31/2020, DEVICE MANUFACTURE DATE: 8/19/2015. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5232198 AND 5231375. ADDITIONALLY, 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. HOWEVER, CAPA (B)(4) WAS OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE OBTAINED A CONTAMINATED NEEDLE STICK INJURY FROM A 27 G X 1/2 IN. BD ECLIPSE 1 ML BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE WHILE TRYING TO ENGAGE THE SAFETY MECHANISM. THE NURSE RECEIVED POST EXPOSURE LAB WORK. NO MEDICATIONS WERE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382357 27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention