BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7560780 · Received June 1, 2018

    Report

    Report Number
    3002682307-2018-00126
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 22, 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
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH 25 SAMPLES TO INVESTIGATE FOR THIS RECORD. WE HAVE CARRIED OUT A LEAKAGE TEST TO CHECK THE POSSIBLE OF LEAKAGE DUE TO ANY DEFECT IN THE SYRINGE AND NO ISSUES WERE IDENTIFIED. AS A RESULT, BD WAS NOT ABLE TO VERIFY THE REPORTED ISSUE. BD BELIEVES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: SAMPLE EVALUATION WE HAVE BEEN PROVIDED WITH 25 SAMPLES. WE HAVE CARRIED OUT A LEAKAGE TEST TO CHECK THE POSSIBLE OF LEAKAGE DUE TO ANY DEFECT IN THE SYRINGE AND IT HAS PROVED TO BE CORRECT. WE COULD NOT CONFIRM 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 QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (FEBRUARY 27TH - 28TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #8057704 (FEBRUARY 26TH - MARCH 5TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #8058724, AND #8050842 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8058729, AND #8050852 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION: ROOT CAUSE ANALYSIS: WE THINK THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION: THE RECEIVED SAMPLES DID NOT PRESENT ANY ISSUE. NO ISSUE FOUND IN THE BHR REVIEW. WE COULD NOT 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. RATIONALE: 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 THE PISTON OF THE BD DISCARDIT¿ II SYRINGE IS NOT RETURNING TO REQUIRED POSITION (0-5%)" FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403812 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802308

    Patients

    Seq Age Sex Outcome Treatment
    1 Other