BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS

    MDR report key: 8561803 · Received April 29, 2019

    Report

    Report Number
    8041187-2019-00331
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 6, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR'S WERE PERFORMED AND THERE WERE NO QUALITY NOTIFICATIONS RAISED IN THE PAST 12 MONTHS AND NO ABNORMALITIES FOUND. PHOTO EVALUATION ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO OBSERVED THE NEEDLE DETACH FROM HUB. SAMPLE EVALUATION ONE ACTUAL SAMPLE WITH OPEN PACKAGE RETURNED FOR INVESTIGATION FROM THE RETURNED SAMPLE, WE HAD OBSERVED THE NEEDLE HUB WITH COVER AND CANNULA DETACH FROM THE HUB. FURTHER ANALYSIS OBSERVED THAT THERE IS NO EPOXY ON THE NEEDLE HUB AND EPOXY ON THE CANNULA. FROM THE RETURNED SAMPLE, OBSERVED THE CANNULA WITH THE EPOXY AND DETACH FROM THE NEEDLE HUB AND NO EPOXY ON THE HUB. INVESTIGATION WAS CARRIED OUT ON NEEDLE ASSEMBLY PROCESS. AT NEEDLE ASSEMBLY LINE, THERE IS DOSING AT THE EPOXY STATION. SUSPECTED THE DOSING OF THE EPOXY TO BE OUT OF POSITION FROM THE AREA WHERE CANNULA JOINS THE HUB. THIS CAUSE THE CANNULA NOT TO BOND TO THE HUB. THIS COULD HAPPEN WHEN THE CANNULA STATION RESTARTS AFTER THERE ARE MACHINE STOPPAGES. THE PRODUCTION TECHNICIAN IS TO REMOVE THE FIRST RACK ONCE THE MACHINE START RUNNING AGAIN TO PREVENT PARTS WITH IMPROPER EPOXY DOSING FROM FLOWING TO THE NEXT STATION. THE PRODUCTION TECHNICIAN MAY FAIL TO REMOVE THE FIRST RACK, THIS RESULT IN THE NONCONFORMANCE PART FLOWING TO THE NEXT PROCESS. PROBABLE ROOT CAUSE COULD BE DUE TO THE DOSING OF EPOXY OUT OF POSITION FROM THE CANNULA JOINS AT HUB AND PRODUCTION TECHNICIAN FAIL TO REMOVE FROM THE FIRST RACK. ON-JOB TRAINING (OJT-41381) WAS UPDATED FOR NEEDLE ASSEMBLY LINE TROUBLESHOOTING FOR EXCESSIVE EPOXY TO REMOVE THE FIRST RACK WHENEVER THERE IS RESTART AFTER CANNULATION STATION STOPPAGE BY 30-OCT-2018. THE AFFECTED BATCH WAS PRODUCED BEFORE THE CORRECTIVE ACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SYRINGE AFTER INJECTION, NURSE FOUND THE NEEDLE SEPARATION FROM NEEDLE HUB AND LEAVED IN THE PATIENT'S BODY. THE BROKEN NEEDLE HAVE BEEN REMOVED BY HAND.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS EXPERIENCED BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SYRINGE AFTER INJECTION, NURSE FOUND THE NEEDLE SEPARATION FROM NEEDLE HUB AND LEAVED IN THE PATIENT'S BODY. THE BROKEN NEEDLE HAVE BEEN REMOVED BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355828 SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 8264079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other