BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 NS 20ML

    MDR report key: 9246521 · Received October 28, 2019

    Report

    Report Number
    3002682307-2019-00570
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 26, 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
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS AND SAMPLES FOR CATALOG 309210 LOT 9071807 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE RETURNED PHOTOS AND SAMPLES CONCLUDED THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS CONCLUDED THAT THE MENTIONED "PARTICLES" CONSIST OF AN ACCUMULATION OF "SLIP AGENT" WHICH IS USED IN THE FORMULATION OF THE POLYPROPYLENE SYRINGES. 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 STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. A TOXICOLOGY MATERIAL RISK ASSESSMENT HAS BEEN COMPLETED AS AN INDICATOR FOR MATERIALS-MEDICATED ADVERSE EFFECTS. ALL TESTS PASSED AND THE REPORTED WHITE PARTICLES ARE INHERENT TO THE PRODUCT DESIGN AND MATERIAL AND SHOULD NOT REPRESENT ANY RISK IF THE PRODUCT IS USED ACCORDING TO THE NORMAL CLINICAL PRACTICES. BD HAS INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTATIVE ACTIONS FOR THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE S2 NS 20ML HAS BEEN FOUND CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE ARE A DIRTIES IN SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE S2 NS 20ML HAS BEEN FOUND CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE ARE A DIRTIES IN SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042602 SYRINGE S2 NS 20ML SYRINGE FMF BECTON DICKINSON, S.A. 9071807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other