BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE

    MDR report key: 6545593 · Received May 4, 2017

    Report

    Report Number
    8041187-2017-00042
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WITHOUT PACKAGING WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE SAFETY SHIELD WAS DISENGAGED. CONCLUSION: ALTHOUGH BD CONFIRMED THE CUSTOMER'S REPORTED DEFECT, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    RESULTS: THE CUSTOMER REPORTED THAT A SAMPLE IS AVAILABLE FOR EVALUATION, BUT IT HAS NOT YET BEEN RETURNED. HOWEVER, THE MANUFACTURING SITE IN (B)(4) COMPLETED A NO SAMPLE INVESTIGATION ON 04/24/2017. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6106031. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT HAS NOT YET BEEN DETERMINED AS THE EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING AND ACTIVATION THE SAFETY SHIELD OF A 23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE, THE SHIELD WENT TO THE SIDE OF THE NEEDLE AND THEN FELL OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324589 23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6106031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other