BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G BD¿ 5 MICRON FILTER NEEDLE 1 1/2 IN

    MDR report key: 6732338 · Received July 21, 2017

    Report

    Report Number
    1911916-2017-00037
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    January 11, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO SAMPLE OR PHOTO SENT IN FOR INVESTIGATION. THERE WERE 51 VISUAL INSPECTIONS PERFORMED ON BATCH 4181641 ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. BASED ON THE DEFECT DESCRIPTION, THIS IS MOST LIKELY AN EPOXY SPLATTER ON THE CANNULA. CONCLUSION: 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 THE CUSTOMER FOUND WHITE FOREIGN MATTER ON THE 19 G BD¿ 5 MICRON FILTER NEEDLE 1 1/2 IN. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514028 19 G BD¿ 5 MICRON FILTER NEEDLE 1 1/2 IN FILTER NEEDLE GAA BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 4181641

    Patients

    Seq Age Sex Outcome Treatment
    1 Other