BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7574749 · Received June 6, 2018

    Report

    Report Number
    3002682307-2018-00141
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 30, 2018
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH 6 AFFECTED SAMPLES TO INVESTIGATE FOR THIS RECORD. AFTER THE ANALYSIS OF THE SAMPLES, THE HIGH SLIDING FORCE TO GLIDE THE PLUNGER ROD WAS VERY APPARENT. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE OF PLUNGER/TIP LEAKAGE. THE REPORTED FUNCTIONALITY DEFECT IS PRODUCED BY IMPROPER INJECTION IN THE BARREL FILLING PHASE. IT COULD OCCUR CAUSE IF THERE IS A PARTICLE INSIDE THE MOLD THAT PRODUCES STRIPES IN THE INTERNAL WALL OF THE BARREL. IN EXTREME CASES, THAT ISSUE COULD PRODUCE FUNCTIONALITY PROBLEMS DURING THE USE OF THE SYRINGE. BASED ON OUR STRICT INSPECTION PLAN, THE REOCCURRENCE OF THIS ISSUE IS VERY LOW. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION. SAMPLE EVALUATION. WE HAVE BEEN PROVIDED WITH 6 AFFECTED SAMPLES. AFTER THE ANALYSIS OF THE SAMPLES, THE HIGH SLIDING FORCE TO GLIDE THE PLUNGER ROD WAS VERY APPARENT, SO WE COULD CONFIRMED THE REPORTED ISSUE. BHR REVIEW. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (FEBRUARY 21ST - 22ND, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7048467 (FEBRUARY 20TH - 27TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7048395, AND #7041289 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7048399, AND #7041294 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PERFORMED SLIDING TEST FOR THIS LOT (MARCH 2ND, 2017), AND ALL VALUES WERE WITHIN SPECIFICATIONS. ROOT CAUSE DESCRIPTION. ROOT CAUSE ANALYSIS. THE REPORTED FUNCTIONALITY DEFECT IS PRODUCED BY IMPROPER INJECTION IN THE BARREL FILLING PHASE. IT COULD OCCUR CAUSE IF THERE IS A PARTICLE INSIDE THE MOLD THAT PRODUCES STRIPES IN THE INTERNAL WALL OF THE BARREL. IN EXTREME CASES, THAT ISSUE COULD PRODUCE FUNCTIONALITY PROBLEMS DURING THE USE OF THE SYRINGE. BASED ON OUR STRICT INSPECTION PLAN, THE RECURRENCE OF THIS ISSUE IS VERY LOW. CONFIRMATION. THE RETURNED SAMPLES PRESENTED HIGH SLIDING FORCE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION. NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD DISCARDIT¿ II SYRINGE MALFUNCTIONED AS"WHEN PREPARING MEDICATION THE PLUNGER WAS HARD TO MOVE AND MANIPULATE. THE HCWS THOUGHT DRUGS WERE CHANGING THE STATE OF SYRINGES HOWEVER IT SEEMS THAT THE WHOLE BATCH 1702247 IS CONCERNED BY THIS PROBLEM, THE SYRINGES ARE HARD, ALMOST "CRYSTALIZED."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417897 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1702247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other