BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 NS 20ML

    MDR report key: 9123899 · Received September 26, 2019

    Report

    Report Number
    3002682307-2019-00519
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 9, 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: BD HAS BEEN PROVIDED WITH PHOTOS AND SAMPLES FOR CATALOG: 309210 TO INVESTIGATE FOR THIS RECORD. AFTER EVALUATION OF THE RETURNED SAMPLES, BD CONCLUDES 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. THE SLIP AGENT MENTIONED 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 REMAINS INSIDE TO ALLOW A GOOD SLIDING PERFORMANCE DURING THE INJECTION OPERATION. TOXICOLOGIC MATERIAL RISK ASSESSMENT TESTS WERE PERFORMED TO DETERMINE PRECLINICAL MATERIAL BIOCOMPATIBILITIES ARE WITHIN ESTABLISHED CRITERIA FOR PRECLINICAL TOXICOLOGICAL SAFETY EVALUATIONS. ALL TESTS PASSED AND THE RISK OF MATERIAL-MEDIATED ADVERSE EFFECTS ASSOCIATED WITH THE PRODUCT APPLICATION IS CONSIDERED EXTREMELY LOW. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE S2 NS 20ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLAKES IN OUR BD DISCARD IT SYRINGE.

    Additional Manufacturer Narrative · 1

    (B)(6). "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9008815. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 8337677. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-12-03. MEDICAL DEVICE LOT #: 9049935. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-18. MEDICAL DEVICE LOT #: 9071807. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-12. MEDICAL DEVICE LOT #: 9088977. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-29. MEDICAL DEVICE LOT #: 9128508. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-08. MEDICAL DEVICE LOT #: 9148820. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-28. " 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 PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE S2 NS 20ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLAKES IN OUR BD DISCARDIT SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920498 BD SYRINGE S2 NS 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other