BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 8043409 · Received November 6, 2018

    Report

    Report Number
    3002682307-2018-00265
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 16, 2018
    Report Date
    December 4, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH FOUR USED AND AFFECTED SAMPLES. THESE WERE FULL OF A DRUG INSIDE AND PRESENTED A SMALL QUANTITY OF THIS DRUG BETWEEN THE FIRST AND SECOND LIP OF THE STOPPER. BD HAS PERFORMED THE LEAKAGE TEST FOR THESE SYRINGES AND NO ISSUE WAS FOUND. BD COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR LOT 1709398: 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 (SEPTEMBER 18TH - 19TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4267, AND Nº4260, IN LOT #87251007 (SEPTEMBER 11TH ¿ 17TH, 2017), IN LOT #7251008 (SEPTEMBER 11TH ¿ 17TH, 2017) AND IN LOT #7258089 (SEPTEMBER 18TH ¿ 25TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7258088, #7254202, #7244149, #7251472, #7244073, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7258051, #7251476, #7244074, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7244063, #7251500, #7258079, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BASED ON THE SAMPLE EVALUATION, BD CONFIRMS THAT A SMALL QUANTITY OF DRUG LEAKED THROUGH THE FIRST LIP OF THE STOPPER. AFTER THAT, BD PERFORMED THE LEAKAGE TEST AND NO DEFECT WAS FOUND. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM MAY HAVE BEEN PRODUCED BECAUSE OF A SMALL DAMAGE IN THE STOPPER LIP, WHICH DURING USE, PRODUCED THE REPORTED ISSUE. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED 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. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD EMERALD¿ SYRINGE LEAKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880824 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709398

    Patients

    Seq Age Sex Outcome Treatment
    1 Other