BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 5ML SYRINGE WITH NEEDLE

    MDR report key: 7157396 · Received January 2, 2018

    Report

    Report Number
    3002682307-2017-00138
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 7, 2017
    Report Date
    January 23, 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

    NO SAMPLE WAS AVAILABLE FOR INVESTIGATION THEREFORE WE WERE NOT ABLE TO FULLY INVESTIGATE THIS INCIDENT AND CANNOT VERIFY THE REPORTED ISSUE. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2020 (B)(6) - (B)(6) 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4220, Nº4210, AND Nº4236, IN LOT #6242444 (B)(6) - (B)(6) 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #6239273, AND #6230484 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6239282, AND #6230006 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. NO SAMPLES AVAILABLE FOR EVALUATION. NO ISSUE FOUND IN THE BHR. WE COULD NOT CONFIRM THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A NURSE WAS USING A BD¿ 5ML SYRINGE WITH NEEDLE, LEAKAGE OCCURRED ON THE PLUNGER ROD WHEN WITHDRAWING THE SOLUTION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366 BD¿ 5ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1609106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other