BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6183294 · Received December 16, 2016

    Report

    Report Number
    8041187-2016-00094
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 22, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 # 5323084. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE REPORTED FAILURE MODE. 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, CAPAS (B)(4) INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IN ADDITIONAL TO THE NO SAMPLE INVESTIGATION THAT WAS PROVIDED ON THE INITIAL MDR, THE FOLLOWING INFORMATION WAS PROVIDED ON 12/29/2016: THE RESULTS OF PREVIOUS INVESTIGATIONS CONFIRM THE REPORTED ISSUE OF ECLIPSE COMPLAINTS REGARDING SAFETY MECHANISM BREAKAGE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. BASED ON THE ABOVE, SITUATION ANALYSIS MSS-16-837-SA HAS BEEN OPENED TO ADDRESS THIS CONCERN. ALSO, AN URGENT PRODUCT ADVISORY NOTICE HAS BEEN RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A 25 G X 5/8 IN. BD ECLIPSE NEEDLE BROKE AS A CLINICIAN ENGAGED IT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833741 25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5323084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other