BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 NS 20ML

    MDR report key: 9751980 · Received February 25, 2020

    Report

    Report Number
    3002682307-2020-00064
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 23, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS AND A SAMPLE FOR CATALOG 309210 LOT 9071807 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS AND SAMPLE SHOWS THE WHITE PARTICLES IN THE SYRINGE AND HAVE DETERMINED THAT THEY ARE 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 ACCUMULATION OF ¿SLIP AGENT¿ WHICH IS USED IN THE FORMULATION OF THE POLYPROPYLENE WHICH IS IN TURN USED TO MANUFACTURE THE 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 STILL REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. TOXICOLOGIC MATERIAL RISK ASSESSMENT TEST WERE COMPLETED AND ALL TESTS PASSED AND MET ALL ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS. BASED ON THE EVALUATION CONDUCTED, IT IS CONCLUDED THAT 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. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE S2 NS 20ML WAS FOUND TO HAVE FOREIGN MATTER INSIDE THE SYRINGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿ THERE IS DIRT/ PARTICLES INSIDE THE 20ML SYRINGE (COMPONENT 309210) IN THE SET."

    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 WAS REPORTED BD SYRINGE S2 NS 20ML WAS FOUND TO HAVE FOREIGN MATTER INSIDE THE SYRINGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿ THERE IS DIRT/ PARTICLES INSIDE THE 20ML SYRINGE (COMPONENT 309210) IN THE SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216060 BD SYRINGE S2 NS 20ML SALINE FLUSH NGT BECTON DICKINSON, S.A. 9071807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other