BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7578907 · Received June 7, 2018

    Report

    Report Number
    3002682307-2018-00136
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 7, 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

    INVESTIGATION RESULTS: SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A BATCH HISTORY REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ALTHOUGH THE DEFECT WAS NOT CONFIRMED FOR THIS INSTANCE, BD HAS RECENTLY INVESTIGATED A SIMILAR COMPLAINT FOR THIS PRODUCT AND FOUND A LEAKAGE MAY OCCUR AS A RESULT OF A DAMAGE IN THE PLUNGER LIP. WITHOUT THE SAMPLE FOR EVALUATION WE CANNOT VERIFY THIS TO BE TRUE FOR THE PRODUCT YOU REPORTED. IF A SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED AND INVESTIGATED FULLY. CONCLUSION: SAMPLE EVALUATION N/A. 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 Nº2028 ((B)(6) 2018). WE HAVE ALSO REVIEWED THE BARREL LOTS #8050842, #8043958, AND #8037757 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8050852, #8043963, #8037764, AND #8030580 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE: ROOT CAUSE ANALYSIS WE CONCLUDE 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: NO SAMPLES AVAILABLE FOR EVALUATION. NO ISSUE FOUND IN THE BHR. WE COULD NOT CONFIRM THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAKAGE FOUND BY THE PLUNGER ON A BD DISCARDIT¿ II SYRINGE DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423040 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other