BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 9192901 · Received October 15, 2019

    Report

    Report Number
    3002682307-2019-00559
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 27, 2019
    Report Date
    November 27, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 307736 LOT 1904262 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE IDENTIFIED THE FOREIGN MATTER AS A LARGE AMOUNT OF SILICONE STUCK AT THE STOPPER OF THE SYRINGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE ORIGIN OF THE REPORTED FOREIGN MATTER CONSISTED OF SILICONE OIL. THIS SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. CORRECT PRESENCE AND QUANTITY OF SILICONE IN THE SYRINGE IS EVALUATED IN OUR ROUTINE MANUFACTURING CONTROLS. IN THAT CASE, BD CONSIDERS THAT BECAUSE OF SOME TEMPORARY ISSUE IN THE SILICONIZATION PROCESS, THERE WAS AN EXCESS OF SILICONE CAUSING THE REPORTED NONCONFORMANCE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ SYRINGE HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE SYRINGE WAS SMUDGY AND UNCLEAN.

    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 BD EMERALD¿ SYRINGE HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE SYRINGE WAS SMUDGY AND UNCLEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984017 BD EMERALD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other