BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE

    MDR report key: 6735095 · Received July 23, 2017

    Report

    Report Number
    3002682307-2017-00017
    Event Type
    Malfunction
    Date Received
    July 23, 2017
    Date of Event
    June 25, 2017
    Report Date
    October 4, 2017
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE WHICH PRESENTED FOREIGN MATTER IN THE FLUID PATH. DUST PARTICLES ARE PRESENTED IN THAT PICTURE. DHR REVIEW: 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 Nº2011 (SEPTEMBER 16 - 17TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4251, AND Nº4252, IN LOT #6249011 (SEPTEMBER 7 - 17TH, 2016). RESEARCH HAS FOUND 1 QN (#8469) RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6249468, #62176314, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6253447, #6249472, AND #6239284 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: AFTER THE EVALUATION OF THE PICTURE OF THE SAMPLE AND THE DISCUSSION WITH OUR PRODUCTION SUPERVISORS, WE HAVE DETERMINED THAT THE FOREIGN MATTER OF THE NONCONFORMANCE CONSISTS OF AN AMOUNT OF AGGLOMERATE DUST PARTICLES, IN THIS CASE CAME FROM THE CHANNELS OF THE BARREL FEEDER IN THE ASSEMBLY MACHINE. WE IDENTIFIED THAT DEFECT DURING MANUFACTURING AND OPENED A QUALITY NOTIFICATION. IN THAT CASE, WE CONSIDER THAT BECAUSE OF A PUNCTUAL FAILURE IN THE SEGREGATION PROCESS BY THE OPERATOR. CONFIRMATION: THE PROVIDED PICTURE PRESENTED THE REPORTED FOREIGN MATTER. ALSO A QN WAS FOUND WITH THE REPORTED FOREIGN MATTER ISSUE. WE CONFIRMED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE FOUND BLACK AND YELLOW FOREIGN MATTER INSIDE OF A BD¿ 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE WHEN OPENING THE PACKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515537 BD¿ 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON, S.A. 1609164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other