BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6805740 · Received August 18, 2017

    Report

    Report Number
    8041187-2017-00077
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 3, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CUSTOMER PHOTOS WERE SUBMITTED AND REVIEWED. IN REVIEW OF THE PHOTOS, A BLACK SUBSTANCE WAS OBSERVED ON THE SYRINGE TIP. UNABLE TO CONFIRM IF THE SUBSTANCES ARE INK AS NO SAMPLES WERE RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7081238. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: ALTHOUGH THE PHOTOS CONFIRMED THE CUSTOMER¿S REPORTED DEFECT, WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLACK INK IN A 23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586087 23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7081238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other