BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 8134272 · Received December 5, 2018

    Report

    Report Number
    3002682307-2018-00302
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 3, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. DHR REVIEW FOR LOT NUMBER 1801380 SHOWS ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2015 (JANUARY 24TH - 25TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4267, IN LOT #8022710 (JANUARY 22ND - 29TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. INVESTIGATION CONCLUSION: BASED ON THE CUSTOMER FEEDBACK, WE THINK THAT THE REPORTED ISSUE COULD BE RELATED SILICONE OIL. THIS SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. CORRECT PRESENCE AND QUANTITY OF SILICONE IN THE SYRINGE IS EVALUATED IN OUR ROUTINE MANUFACTURING CONTROLS. IN THAT CASE, WE CONSIDER THAT BECAUSE OF SOME TEMPORARY ISSUE IN THE SILICONIZATION PROCESS, THERE COULD HAVE BEEN AN EXCESS OF SILICONE CAUSING THE REPORTED NONCONFORMANCE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: 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 THAT BD EMERALD¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS 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 BD EMERALD¿ SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972809 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1801380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other