BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6583410 · Received May 22, 2017

    Report

    Report Number
    8041187-2017-00044
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    April 12, 2017
    Report Date
    July 29, 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: 126 UNUSED REPRESENTATIVE SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE EVALUATED AND THE SAFETY SHIELDS DID NOT FALL OFF. CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

    RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6079229. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. 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. REMEDIAL ACTION REQUIRED: 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 THE PINK SAFETY SHIELD OF A 25 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE FELL OFF DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362169 25 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6079229

    Patients

    Seq Age Sex Outcome Treatment
    1 Other