BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II 20 ML SYRINGE

    MDR report key: 8496235 · Received April 9, 2019

    Report

    Report Number
    3002682307-2019-00235
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    December 14, 2018
    Report Date
    May 23, 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: BD HAS BEEN PROVIDED WITH PHOTOS AND AFFECTED SAMPLE FOR CATALOG 300296 LOT 1802243 TO INVESTIGATE FOR THIS RECORD. AFTER EVALUATION OF THE PHOTOS AND RETURNED SAMPLES, BD VERIFIES THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. THE PARTICLES CONSIST OF AN ACCUMULATION OF "SLIP AGENT" WHICH IS USED IN THE FORMULATION AND MANUFACTURING OF THE POLYPROPYLENE SYRINGES. THE 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. TOXICOLOGIC MATERIAL RISK ASSESSMENT TESTS HAVE BEEN CONDUCTED AND THEY HAVE ALL PASSED ALL ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS AND SHOULD NOT REPRESENT ANY RISK IF THE PRODUCT IS USED ACCORDING TO NORMAL PRACTICES. CAPA#(B)(4) WAS INITIATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD DISCARDIT¿ II 20 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE USE, THE MEDICAL STAFF NOTICES WHITE PARTICLES IN THE SYRINGE. THE INCIDENT HAPPENS MORE THAN ONCE ON THIS LOT NUMBER. ONLY ONE DEVICE HAS BEEN KEPT FOR THE INVESTIGATION PURPOSES. THE DEVICE HAS NOT BEEN CONTAMINATED."

    Additional Manufacturer Narrative · 1

    (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 FOREIGN MATTER OCCURRED WITH A BD DISCARDIT¿ II 20 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE USE, THE MEDICAL STAFF NOTICES WHITE PARTICLES IN THE SYRINGE. THE INCIDENT HAPPENS MORE THAN ONCE ON THIS LOT NUMBER. ONLY ONE DEVICE HAS BEEN KEPT FOR THE INVESTIGATION PURPOSES. THE DEVICE HAS NOT BEEN CONTAMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287738 BD DISCARDIT¿ II 20 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802243 00382903002962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other