BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7985395 · Received October 19, 2018

    Report

    Report Number
    3002682307-2018-00249
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 28, 2018
    Report Date
    November 1, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. DHR REVIEW FOR BATCH # 1804227: 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 Nº2022 (APRIL 17TH - 18TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4208, Nº4204, Nº4252, AND Nº4251, IN LOT #8106962, LOT #8099689, #LOT #8085767 AND LOT #8075964. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8107653, #8099994, #8085749, #8072878, AND #8075987, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8107657, #8099501, #8085753, #8075991, AND #8072883, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1804329: 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 Nº2011 (APRIL 20TH ¿ 21ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4208, Nº4204, Nº4252, AND Nº4251, IN LOT #8106962. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8107653, #8099994, #8085749, #8072878, AND #8075987, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8107657, #8099501, #8085753, #8075991, AND #8072883, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BASED ON THE CUSTOMER DESCRIPTION, BD CONSIDERS THAT THE PARTICLES COULD BE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. IF THE PARTICLES ARE COMPOSED OF LUBRICANT, IT 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 WITH THE USE OF THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1804227; MEDICAL DEVICE EXPIRATION DATE: 2023-03-31; DEVICE MANUFACTURE DATE: 2018-04-09; MEDICAL DEVICE LOT #: 1804239; MEDICAL DEVICE EXPIRATION DATE: 2023-03-31; DEVICE MANUFACTURE DATE: 2018-04-09. (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 WITH THE USE OF THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823377 BD DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other