BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1 1/2 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE

    MDR report key: 6828902 · Received August 29, 2017

    Report

    Report Number
    8041187-2017-00088
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    August 7, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 4 REPRESENTATIVE SAMPLES (SEALED PACKAGE) WERE RECEIVED. FURTHER EVALUATION ON THE SAMPLE AND NO SAFETY SHIELD DISENGAGED AND NO DAMAGE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. CAPA # (B)(4) EXISTS TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A NO SAMPLE INVESTIGATION HAS BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # (6296429). HOWEVER, A SAMPLE HAS BEEN RECEIVED AND FORWARDED TO THE MANUFACTURING SITE IN TUAS, (B)(4) FOR FURTHER EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.  CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION IS STILL IN PROGRESS. HOWEVER, CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE 22 G X 1 1/2 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE FAILED TO COVER THE NEEDLE RESULTING IN A NEEDLE STICK INJURY. HEALTHCARE WORKER RECEIVED POST EXPOSURE LAB WORK. NO ADDITIONAL TREATMENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606847 22 G X 1 1/2 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6296429

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention