BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LS PRECISE

    MDR report key: 11980869 · Received June 10, 2021

    Report

    Report Number
    8041187-2021-00490
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: FIVE ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE SAMPLES, A DAMAGED BARREL TIP WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE TEAM INVESTIGATED DIFFERENT SECTIONS OF THE SYRINGE MACHINES AND MATCHED THE POTENTIAL AREA WHICH COULD LEAD TO THE DAMAGED BARREL. THE DAMAGED BARREL TIP COULD HAVE OCCURRED AT THE ASSEMBLY MACHINE. WHEN THERE IS A MOLDED PLUNGER JAMMED AT THE ASSEMBLY DIAL WHICH CAUSES THE MACHINE DIALS TO BE UNABLE TO TURN, THE PRODUCTION TECHNICIAN REMOVES THE TOP THUMB-PRESS OF MOLDED PLUNGER WITH A CUTTER, THEN SLOWLY ADJUSTS THE DIALS UNTIL THE JAMMED PLUNGER FREE FROM THE TIGHT SPOT. THE PROBABLE ROOT CAUSE OF THIS NONCONFORMANCE COULD BE DUE TO THE THUMB-PRESS OF THE PLUNGER BEING STUCK INSIDE THE LOWER TOOLING. THIS RESULTS IN THE SYRINGE BARREL TUP TO BE UNABLE TO SIT FULLY IN THE LOWER TOOLING AND BEING FORCED TO PRESS INTO THE TOOLING, CAUSING THE BARREL TIP TO BE DAMAGED. THE ON-THE-JOB TRAINING WILL BE REVISED TO ADD AN ADDITIONAL STEP TO CLEAR THE MOLDED PLUNGER THUMB-PRESS FROM THE LOWER TOOLING AND COMMUNICATION TO THE PRODUCTION TECHNICIAN TO RAISE AWARENESS ON THE REPORTED DEFECT WILL OCCUR. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LS PRECISE TIP WAS DAMAGED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIP OF THE SYRINGE OF 50ML HYPO WERE TWISTED AND COULD NOT BE USED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LS PRECISE TIP WAS DAMAGED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIP OF THE SYRINGE OF 50ML HYPO WERE TWISTED AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876538 SYRINGE 50ML LS PRECISE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9025715

    Patients

    Seq Age Sex Outcome Treatment
    1