BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH NEEDLE

    MDR report key: 7162137 · Received January 3, 2018

    Report

    Report Number
    3002682307-2017-00148
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 12, 2017
    Report Date
    February 5, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN COMPLETED WITH THE AFFECTED SAMPLE. VISUAL INSPECTION OF THE SAMPLE REVEALED PLASTIC FLASHES ON THE TOP OF THE SYRINGE TIP. BASED ON THE SAMPLE, THIS FLASH WAS PRODUCED IN THE INJECTION PROCESS, DUE TO A PUNCTUAL INCREASE OF THE INJECTION PRESSURE OR AN ISSUE RELATED TO THE CLOSE OF THE MOLD. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOT #7100035, #7089485, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. THE RECURRENCE OF THIS ISSUE SHOULD BE VERY LOW TO NEGLIGIBLE AND SHOULD NOT REPRESENT ANY IMPACT TO THE HEALTH OF THE PATIENT OR USER. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A BD¿ 20 ML SYRINGE WITH NEEDLE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5593 BD¿ 20 ML SYRINGE WITH NEEDLE HYPODERMIC SYRINGE W/ NEEDLE FMF BECTON DICKINSON, S.A. 1704164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other