BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE E/T EMERALD

    MDR report key: 8139476 · Received December 6, 2018

    Report

    Report Number
    3002682307-2018-00300
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 19, 2018
    Report Date
    January 15, 2019
    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
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. THE PROVIDED PICTURE PRESENTED THE TIP BROKEN. BD CONFIRMS THE REPORTED ISSUE. COMPLAINT TRENDING REVIEW OF THIS LOT AND DEFECT REVEALS NO MORE COMPLAINTS. BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKAGED IN MACHINE Nº2017 (MARCH 8TH ¿ 9TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, IN LOT #8065549 (MARCH 6TH ¿ 15TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8062923, #7258069, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. INVESTIGATION CONCLUSION: THE MATERIAL USED TO MANUFACTURE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE TIP COULD BREAK BECAUSE OF THE STRONG CONDITIONS DURING USE OF THE PRODUCT. ROOT CAUSE DESCRIPTION: NOT ABLE TO CONFIRM THE REPORTED ISSUE. POSSIBLE CRACKED DUE TO STRONG CONDITIONS DURING USE OF THE PRODUCT. RATIONALE: BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF BD¿ SYRINGE E/T EMERALD WAS BROKEN DURING USE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE TIP OF BD¿ SYRINGE E/T EMERALD WAS BROKEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980080 BD¿ SYRINGE E/T EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1803152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other