BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8078505 · Received November 16, 2018

    Report

    Report Number
    3002682307-2018-00282
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 26, 2018
    Report Date
    December 5, 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
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAS BEEN PROVIDED WITH TWO AFFECTED SAMPLES. AFTER THE ANALYSIS OF THE SAMPLES, THE HIGH SLIDING FORCE TO GLIDE THE PLUNGER ROD WAS VERY APPARENT, SO WE COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR LOT # 1602235: BD HAS 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 Nº2026 (B)(6) 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4219, Nº4214, Nº4206, AND Nº4201, IN LOT #6053199 (B)(6) 2016) AND IN LOT #6060010 (B)(6) 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #6056283, #6050332, #60043037, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #6050341, #60043043, #6036038, #6056287 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PERFORMED SLIDING TEST FOR THIS LOT (B)(6) 2016), AND ALL VALUES WERE WITHIN SPECIFICATIONS. AFTER THE EVALUATION OF THE RECEIVED SAMPLES, BD CONCLUDES THAT 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. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED 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 THE BD DISCARDIT II SYRINGE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921494 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1602235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other