BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP

    MDR report key: 7914134 · Received September 27, 2018

    Report

    Report Number
    3002682307-2018-00235
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 8, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH THREE REFERENCE SAMPLES. THE INSPECTION OF THE RETURNED SAMPLES DID NOT PRESENT ANY ISSUE, NO DEFECT IN THE PROVIDED SAMPLES. WE COULD NOT CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR BATCH 1803159: 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 Nº2013 (MARCH 13TH ¿ 16TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4219, Nº4218, AND Nº4207, IN LOT #8029665 (JANUARY 29TH ¿ FEBRUARY 5TH, 2018), LOT #8057706 (FEBRUARY 26TH ¿ MARCH 5TH, 2018) AND IN LOT #8071864 (MARCH 12TH ¿ 17TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8072887, #8065750, #8058732, #8050966, #8043968, #8037767, 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 STRONG CONDITIONS DURING USE OF THE PRODUCT. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS LOW 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 WITH THE USE OF THE BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP THERE WAS AN ISSUE WITH TIP BREAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 WITH THE USE OF THE BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP THERE WAS AN ISSUE WITH TIP BREAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755474 BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other