BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 8311993 · Received February 6, 2019

    Report

    Report Number
    3002682307-2019-00128
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 15, 2019
    Report Date
    March 18, 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: ¿1806152: 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 (JUNE 7TH - 8TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8155592, #8148567. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8156556, #8149705, #8142763, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8156560, #8142767, #8144709, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1807214: 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 21ST - 22ND, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8197930. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8198680, #8185517, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8198684, #8185526, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1807134: 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 11TH - 12TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE IN LOT #8186940. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8185517, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8163671, #8185526, 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, BD 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. BD HAS INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #207816.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II SYRINGES W/O NEEDLES WERE NOTED TO CONTAIN FOREIGN MATTER CONTAMINATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1806152, MEDICAL DEVICE EXPIRATION DATE: 05/31/2023, DEVICE MANUFACTURE DATE: 05/31/2018. MEDICAL DEVICE LOT #: 1807214, MEDICAL DEVICE EXPIRATION DATE: 06/30/2023, DEVICE MANUFACTURE DATE: 07/17/2018. MEDICAL DEVICE LOT #: 1807134, MEDICAL DEVICE EXPIRATION DATE: 06/30/2023, DEVICE MANUFACTURE DATE: 06/20/2018. 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 AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II SYRINGES W/O NEEDLES WERE NOTED TO CONTAIN FOREIGN MATTER CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106680 BD DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other