BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 8125087 · Received December 3, 2018

    Report

    Report Number
    3002682307-2018-00306
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903077311
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR REVIEW FOR LOT # 1809162: WE HAVE 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 Nº2012 (SEPTEMBER 3RD ¿ 6TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4268, Nº4259, Nº4210, AND Nº4205, IN LOT #8239897, LOT #8246951, LOT #8233533, AND LOT #8239805. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8240574, #8233662, #8212970, #8205048, #8247767, #8239898, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 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, WE THINK THAT THE SYRINGE TIP COULD BREAK AS A CONSEQUENCE OF THE STRONG CONDITIONS DURING USE OF THE PRODUCT. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE 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 EMERALD¿ SYRINGE 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965036 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1809162 00382903077311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other