BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE

    MDR report key: 6745719 · Received July 26, 2017

    Report

    Report Number
    1911916-2017-00046
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    January 19, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6180926, MEDICAL DEVICE EXPIRATION DATE: 07/31/2021, DEVICE MANUFACTURE DATE: 06/28/2016. MEDICAL DEVICE LOT #: 6242757, MEDICAL DEVICE EXPIRATION DATE: 09/30/2021, DEVICE MANUFACTURE DATE: 06/29/2016. INVESTIGATION SUMMARY: THE COMPLAINTS LAB RECEIVED ONE SAMPLE. THE NEEDLE WAS ALREADY ATTACHED TO A POSIFLUSH SYRINGE. THE SAMPLE WAS VISUALLY INSPECTED. NO PARTICLE WAS FOUND INSIDE THE PREFILLED SYRINGE. NO PARTICLE WAS FOUND ON THE CANNULA SHAFT OR INSIDE THE NEEDLE HUB. BASED ON THE SAMPLE RECEIVED THE INVESTIGATION CONCLUDED:UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. UDI#: (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES UPON VISUAL INSPECTION HE FOUND A FLOATING PARTICLE ON AN 18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523385 18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE HYPODERMIC NEEDLES GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other