BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 7957696 · Received October 11, 2018

    Report

    Report Number
    3002682307-2018-00241
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 19, 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 · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE, THE PROVIDED PICTURE PRESENTED A SYRINGE IN WHICH THE DRUG HAD PASSED THROUGH THE STOPPER. BD COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR LOT # 1802379: 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 Nº2015 (FEBRUARY 19TH - 20TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4267, IN LOT #8050751 (FEBRUARY 19TH ¿ 21ST, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8050968, #8043970, #8037769, #8030584, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8050973, #8043973, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE STOPPER LOTS #8050977, #8043977, #8037828, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BASED ON THE CUSTOMER FEEDBACK AND THE PROVIDED PICTURES, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE STOPPER LIP OR IN THE SYRINGE BARREL WALL. AFTER DISCUSSING WITH OUR MANUFACTURING TECHNICIANS, BD SUGGESTS THE ROOT CAUSE OF THE PROBLEM AS A DAMAGE IN THE STOPPER LIP OR IN THE BARREL WALL DURING MANUFACTURING, THAT DAMAGE PRODUCED AN INCORRECT INTERACTION BETWEEN THESE TWO PIECES, PRODUCING THE REPORTED ISSUE. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY 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 EMERALD¿ SYRINGE LEAKED AT THE PISTON SEAL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 EMERALD¿ SYRINGE LEAKED AT THE PISTON SEAL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796730 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other