BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 7072354 · Received November 30, 2017

    Report

    Report Number
    3009081593-2017-00025
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    September 15, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE NOT PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. PHOTOS WERE RECEIVED. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE PHOTOS NO DAMAGE OR DEFORMATION CAN BE SEEN ON THE DEVICE WHICH WOULD MAKE IT SENSITIVE TO SYRINGE UNCLIPPING. THE FLANGE OF THE SYRINGE SEEM TO BE INTACT, NOT BROKEN. COMPLAINT UNCONFIRMED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 5300222, EXPIRATION DATE: 10/31/2019, MANUFACTURE DATE: 10/27/2015. MEDICAL DEVICE LOT #: 5243391, EXPIRATION DATE: 08/31/2019, MANUFACTURE DATE: 08/31/2015. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA SAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE MALFUNCTIONED BEFORE USE AS THE SYRINGE HAS NOT ADHERED TO THE OUTER PROTECTOR. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852250 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other