BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY 25 G X 1 IN. THIN WALL NEEDLE

    MDR report key: 6535788 · Received May 1, 2017

    Report

    Report Number
    8041187-2017-00043
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    March 16, 2017
    Report Date
    May 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5288042. 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. REMEDIAL ACTION REQUIRED: 46905 AND 56413 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).

    Additional Manufacturer Narrative · 1

    RESULTS: AS PREVIOUSLY REPORTED, A SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER RETURNED FOUR PHOTOS FOR INVESTIGATION. A PHOTO INSPECTION REVEALED CLOSE UP PICTURES OF A SAFETY SHIELD WITH NO OTHER ASSEMBLED PARTS. THERE WAS NO VISUAL DAMAGE OBSERVED ON THE SAFETY SHIELD. CONCLUSION: ALTHOUGH THE CUSTOMER'S PHOTOS SHOWED A DETACHED SAFETY SHIELD, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY 25 G X 1 IN. THIN WALL NEEDLE FELL OFF WHILE THE USER WAS DRAWING UP AN INFLUENZA VACCINATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317073 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY 25 G X 1 IN. THIN WALL NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5288042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other