BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8782258 · Received July 11, 2019

    Report

    Report Number
    3002682307-2019-00400
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 4, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 301948 LOT 1811162 TO INVESTIGATE FOR THIS RECORD. AFTER THE EVALUATION OF THE RETURNED PHOTO, BD IDENTIFIED THE FOREIGN MATTER AS EMBEDDED CONTAMINATION IN THE PLUNGER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE EMBEDDED PARTICLES DEFECT WAS PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), DIFFERENT GASES ARE PRODUCED INSIDE THE MOLD. DURING NORMAL PRODUCTION THESE GASES ARE EXPELLED THROUGH SOME CONDUITS, OUTSIDE THE MOLD CAVITY. IN THIS CASE THE EXPULSION WAS NOT DONE CORRECTLY, AND SOME GASES REMAINED IN THE MOLD CAVITY AND PRODUCE THE BURNT SYRINGE PIECE. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE BURNT PLASTIC IS EMBEDDED IN THE PLUNGER WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED FOREIGN MATTER CONTAMINATION AND SCALE MARKING PERMANENCY ISSUES. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER WAS NOTICED ON THE PLUNGER ROD BEFORE UNWRAPPED THE PACKAGE. DEFECTIVE PRODUCT WAS NOT USED.

    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 CHINA EXPERIENCED FOREIGN MATTER CONTAMINATION AND SCALE MARKING PERMANENCY ISSUES. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER WAS NOTICED ON THE PLUNGER ROD BEFORE UNWRAPPED THE PACKAGE. DEFECTIVE PRODUCT WAS NOT USED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575431 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other