BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1 IN. BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE

    MDR report key: 6719930 · Received July 17, 2017

    Report

    Report Number
    1911916-2017-00029
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    January 1, 2017
    Report Date
    July 17, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINTS LAB RECEIVED ONE OPEN SAMPLE ATTACHED TO A 3ML SYRINGE. THE SAMPLE WAS VISUALLY INSPECTED AND THE NEEDLE HUB WAS FOUND TO BE CRACKED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED DEFECTS FOR BURNS, FLASH, AND DISCOLORATION FOR THE REPORTED LOT # 6152995. THESE DEFECTS WOULD CAUSE BREAKAGE. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS A MANUFACTURING DEFICIENCY. A FORMAL CAPA HAS NOT BEEN INITIATED AND A SITUATION ANALYSIS, (B)(4), HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL 18 G X 1 IN. BD¿ GENERAL USE STERILE HYPODERMIC NEEDLES SEPARATED FROM THE HUB WHEN BEING ATTACHED TO A SYRINGE OR WHEN BEING USED WITH A VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500122 18 G X 1 IN. BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLES FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6152995

    Patients

    Seq Age Sex Outcome Treatment
    1 Other