BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS EMERALD

    MDR report key: 12104392 · Received July 1, 2021

    Report

    Report Number
    3002682307-2021-00299
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    April 23, 2021
    Report Date
    August 31, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2002140. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE NOT RETURNED FOR THIS INCIDENT, TWENTY RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER REVIEW. THE RETAINED SAMPLES WERE EVALUATED AND NO SIGNS OF DEFECT WERE OBSERVED. THE MATERIAL USED TO MANUFACTURE THE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY SIGNS OF DAMAGE PRODUCT, SUCH AS A BROKEN THUMB PRESS. BASED ON THE CAMERA SYSTEM, WE BELIEVE THIS DAMAGE COULD HAVE RESULTED FROM STORAGE CONDITIONS DURING MANUFACTURE. IF THE PLUNGER IS STILL HOT WHEN THE PRODUCT IS MOVED TO STORAGE, THE PLUNGER MAY BECOME DAMAGED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LS EMERALD PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END OF THE PLUNGER IS BROKEN, CREATING A SHARP EDGE AT THE "THUMB GRIP". THIS WAS IDENTIFIED BEFORE USE. NO ADVERSE EVENTS REPORTED.

    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 5ML LS EMERALD PLUNGER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE END OF THE PLUNGER IS BROKEN, CREATING A SHARP EDGE AT THE "THUMB GRIP". THIS WAS IDENTIFIED BEFORE USE. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995504 SYRINGE 5ML LS EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 2002140

    Patients

    Seq Age Sex Outcome Treatment
    1