BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 8318412 · Received February 7, 2019

    Report

    Report Number
    3002682307-2019-00129
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 16, 2019
    Report Date
    March 18, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903002962
    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: DHR: 1806198: 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 Nº2020 (JUNE 15TH - 17TH, 2018). SYRINGES WERE ASSEMBLED IN LOT #8162871. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8163667, #8156556, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8163671, #8156560 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE WHITE PARTICLES CONSIST OF ACCUMULATION OF A SLIP AGENT WHICH IS USED WITH THE FORMULATION OF THE POLYPROPYLENE SYRINGE. THIS SLIP AGENT IS USED TO FACILITATE THE MOVEMENT OF THE PLUNGER ALONG THE BARREL. DURING THE MANUFACTURING PROCESS, THE LUBRICANT FORMS A MICROSCOPIC LAYER IN THE INTERNAL/EXTERNAL WALLS OF THE BARREL. WHEN THE PLUNGER IS MOVED BACKWARDS DURING THE FILLING OF THE SYRINGE, MOST OF THIS MICROSCOPE LAYER OF LUBRICANT IS DRAGGED BEHIND THE PLUNGER AND A SMALL QUANTITY REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. TOXICOLOGY RISK MATERIAL RISK ASSESSMENT TESTS HAVE BEEN CONDUCTED AND ALL TESTS PASSED AND MET ACCEPTABLE STANDARDS. BD HAS INITIATED THE PROPER CORRECTIVE AND PREVENTATIVE ACTIONS FOR THIS ISSUE. CAPA #207816.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WERE WHITE PARTICLES INSIDE THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 BEFORE USE OF THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WERE WHITE PARTICLES INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111945 BD DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1806198 00382903002962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other