BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G BD¿ 5 MICRON FILTER NEEDLE 1 1/2 IN., STERILE, SINGLE USE

    MDR report key: 6735025 · Received July 23, 2017

    Report

    Report Number
    1911916-2017-00054
    Event Type
    Malfunction
    Date Received
    July 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4181641; MEDICAL DEVICE EXPIRATION DATE: 09/30/2019; DEVICE MANUFACTURE DATE: 6/1/2014; (B)(4). MEDICAL DEVICE LOT #: 4181640; MEDICAL DEVICE EXPIRATION DATE: 09/30/2019; DEVICE MANUFACTURE DATE: 6/1/2014; (B)(4). ASSEMBLY BATCH 4218694 WAS USED IN THE PRODUCTION OF BOTH OF THESE BATCHES. THERE WERE 51 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. BASED ON THE DEFECT DESCRIPTION, THIS IS MOST LIKELY AN EPOXY SPLATTER ON THE CANNULA. CLEANING WAS PERFORMED SIX TIMES DURING THE PRODUCTION OF THIS BATCH. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    WHITE FOREIGN MATTER WAS OBSERVED ON THE 19 G BD¿ 5 MICRON FILTER NEEDLE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515531 19 G BD¿ 5 MICRON FILTER NEEDLE 1 1/2 IN., STERILE, SINGLE USE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other