BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 8354067 · Received February 20, 2019

    Report

    Report Number
    3002682307-2019-00156
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    February 5, 2019
    Report Date
    April 3, 2019
    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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 1712181: 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 Nº2022 (DECEMBER 10TH - 12TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #7338937. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARRELS LOTS #7338615, AND #7331815 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #7338621, AND #7331819 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1805205: 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 Nº2011 (MAY 12TH ¿ 13TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #8127719. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARRELS LOTS #8128591, AND #8119953 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8128595, AND #8119957 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1806209: 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 Nº2022 (JUNE 18TH - JULY 10TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #8186940 AND LOT #8169671. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARRELS LOTS #8185517, AND #8163667 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8185526, AND #8163671 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLES. AFTER THE EVALUATION OF THE RETURNED SAMPLES, WE CONFIRMED THE REPORTED ISSUE, AND CONCLUDED THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. CONCLUSION(S): PARTICLES COMPOSED BY LUBRICANT, WHICH IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2-PIECE SYRINGES. WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #207816.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS VISIBLE IN THE DISCARDIT¿ II SYRINGE W/O NEEDLE DURING USE. LOT #'S 1712181,1805205, AND 1806209 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1712181; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-12-04; MEDICAL DEVICE LOT #: 1805205; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-05-07; MEDICAL DEVICE LOT #: 1806209; MEDICAL DEVICE EXPIRATION DATE: 2023-05-31; DEVICE MANUFACTURE DATE: 2018-06-12. (B)(6). 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 WHITE FOREIGN MATTER WAS VISIBLE IN THE DISCARDIT¿ II SYRINGE W/O NEEDLE DURING USE. LOT #'S 1712181,1805205, AND 1806209 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149411 DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other