BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 7060329 · Received November 27, 2017

    Report

    Report Number
    8041187-2017-00178
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6197455. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ECLIPSE¿ NEEDLE MALFUNCTIONED AFTER USE AS THE SAFETY DEVICE ON A NEEDLE BROKE OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839025 BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6197455 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other