BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 8617489 · Received May 16, 2019

    Report

    Report Number
    3002682307-2019-00314
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 16, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS PROVIDED WITH A PHOTO AND SAMPLES FOR CATALOG 301948 LOT 1811364 TO INVESTIGATE THE RECORD. THE ANALYSIS OF THE SAMPLE SHOWED SMALL BLACK PARTICLES IN THE BODY OF THE SYRINGE, OUTSIDE THE FLUID PATH. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS DETERMINED THAT THE FOREIGN MATTER OF THE NON-CONFORMANCE CONSISTS OF VERY SMALL PIECE OF DUST MIXED WITH THE SILICONE OF THE SYRINGE. THE SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. THE DUST IN THIS CASE CAME FROM THE HOPPER OF THE ASSEMBLY MACHINE. IN THAT CASE, BD CONSIDERS THAT BECAUSE OF A PUNCTUAL FAILURE IN THE CLEANING PROCEDURES BY THE OPERATOR, THE PRESENCE OF THIS PARTICULATES IN THE HOPPER WAS NOT CORRECTLY AVOIDED MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED MOLD PRESENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, IT WAS FOUND BLACK FOREIGN MATTER ON PLUNGER, LIKE MOLD.

    Additional Manufacturer Narrative · 1

    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 THE SYRINGE S2 20ML 18GA 1-1/2IN BD (B)(4) EXPERIENCED MOLD PRESENCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, IT WAS FOUND BLACK FOREIGN MATTER ON PLUNGER, LIKE MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407891 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other