BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 7135318 · Received December 20, 2017

    Report

    Report Number
    3002682307-2017-00128
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 27, 2017
    Report Date
    January 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLE. AFTER THAT WE COULD DETERMINE DAMAGE IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. 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 N¿2020 (AUGUST 30TH - SEPTEMBER 9TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, N¿4255, N¿4254, N¿4237, N¿4220, N¿4210, AND N¿4236, IN LOT #6242444 (AUGUST 29TH - SEPTEMBER 5TH, 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. CONFIRMATION THE PROVIDED SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A BD" SYRINGE. A NURSE FOUND SOLUTION LEAKED FROM PLUNGER ROD WHEN WITHDRAWING SOLUTION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912236 BD SYRINGE WITH NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON, S.A. 1609106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other