BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6360932 · Received February 27, 2017

    Report

    Report Number
    8041187-2017-00024
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 23, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF THE AFFECTED DEVICE FOR ANALYSIS. A PHOTO INSPECTION SHOWED THE SAFETY SHIELD DISENGAGED FROM THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5323003. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: ALTHOUGH THE CUSTOMER'S PHOTO SHOWED THE INDICATED DEFECT, 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. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) HAVE BEEN 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 AFTER A NURSE HAD GIVEN A VITAMIN B12 INJECTION WITH A 22 G X 1 1/2 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE, HE/SHE ACTIVATED THE SAFETY MECHANISM ON A COUNTER TOP AND THE SAFETY SHIELD BROKE OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143927 22 G X 1 1/2 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5323003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other