BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS 21X1-1/2 AN EMERALD

    MDR report key: 9130248 · Received September 27, 2019

    Report

    Report Number
    3002682307-2019-00524
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 10, 2019
    Report Date
    November 4, 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
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PHOTO AND A SAMPLE FOR CATALOG 307737 LOT 1904119 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO AND SAMPLE SHOWS A HOOKED POINT NEEDLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUES. BD FRAGA PLANT IS PROVIDED WITH CLOSED CARTRIDGES OF CANNULAS BY SISTER BD PLANTS. THESE CARTRIDGES ARE DIRECTLY INTRODUCED IN THE ASSEMBLY MACHINE AND ASSEMBLED INTO THE HUB WITH THE GROUND END IN THE HUB. AFTERWARDS, AN IN-LINE CAMERA SYSTEM THAT INSPECTS 100% THE POINT OF THE NEEDLES, REJECTING THE DEFECTIVE ONES. SINCE DEFECTIVE SAMPLE WAS FOUND DURING USE, AND REVIEW OF DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT, NO ROOT CAUSE RELATED TO NEEDLE MANUFACTURING PROCESS WAS POSSIBLE TO DETERMINE AT THIS TIME. IN ADDITION, BD MUST CONSIDER THAT THE CANNULA POINT IS THE MOST CRITICAL AND FRAGILE PART OF THE NEEDLE AND CAN BE DAMAGED VERY EASILY. THE HANDLING OF THE PRODUCT ONCE THE SHIELD HAS BEEN REMOVED, THE WITHDRAWING OF MEDICATION FROM THE VIAL OR THE RE-ASSEMBLING OF THE SHIELD (PRACTICE WHICH SHOULD NOT BE DONE) NEEDS TO BE DONE CAREFULLY TO AVOID ANY RISK OF DAMAGE THE CANNULA POINT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 10ML LS 21X1-1/2 AN EMERALD EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED AN INFORMATIVE EMAIL FROM THE END USER REPORTING THAT THERE WAS A DEFECT ON THE NEEDLE OF A 10 ML EMERALD SYRINGE. APPARENTLY THE NURSE CLAIMED THAT SHE HAD GREAT DIFFICULTY PENETRATING THE VEIN, AND AFTER SHE MADE IT, SHE COULDN'T DRAW BACK THE PLUNGER OF THE SYRINGE IN ORDER TO FILL THE SYRINGE WITH BLOOD. THEY HAVE SENT US A PHOTO THAT SHOWS A DISTORTED CUT OF THE BEVEL OF THE NEEDLE.

    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 SYRINGE 10ML LS 21X1-1/2 AN EMERALD EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED AN INFORMATIVE EMAIL FROM THE END USER REPORTING THAT THERE WAS A DEFECT ON THE NEEDLE OF A 10 ML EMERALD SYRINGE. APPARENTLY THE NURSE CLAIMED THAT SHE HAD GREAT DIFFICULTY PENETRATING THE VEIN, AND AFTER SHE MADE IT, SHE COULDN'T DRAW BACK THE PLUNGER OF THE SYRINGE IN ORDER TO FILL THE SYRINGE WITH BLOOD. THEY HAVE SENT US A PHOTO THAT SHOWS A DISTORTED CUT OF THE BEVEL OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925983 SYRINGE 10ML LS 21X1-1/2 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1904119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other