BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE

    MDR report key: 6751593 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00068
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    January 3, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A DEVICE HISTORY REVIEW WAS COMPLETED ON LOT# 5211671, IT HAD 151 VISUAL INSPECTIONS PERFORMED ON 7,550 PARTS WITH ZERO DEFECTS NOTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FOREIGN MATTER IN FLUID PATH WAY 30 G BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE SYRINGE . NO MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532588 30 G BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE CONVENTIONAL NEEDLES FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5239605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other