BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD 2ML SYRINGE

    MDR report key: 11032846 · Received December 17, 2020

    Report

    Report Number
    3002682307-2020-00412
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 18, 2020
    Report Date
    March 18, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1811233. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE STOPPER WAS OBSERVED DEFECTIVE AND STUCK AGAINST THE BARREL WALL. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DUE TO AN ERROR DURING THE ASSEMBLY PROCESS WHICH CAUSED A MISALIGNMENT AND RESULTED IN INCORRECT ASSEMBLY OF THE STOPPER COMPONENT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD EMERALD¿ 2ML SYRINGE EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED A PROBLEM WITH ONE OF THE 2 ML EMERALD SYRINGES (REF: 307727) FROM LOT 1811233. THE RUBBER PART OF THE PLUNGER SEEMS TO HAVE MELTED, WHICH MAKES THE SYRINGE UNUSABLE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD EMERALD¿ 2ML SYRINGE EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED A PROBLEM WITH ONE OF THE 2 ML EMERALD SYRINGES (REF: 307727) FROM LOT 1811233. THE RUBBER PART OF THE PLUNGER SEEMS TO HAVE MELTED, WHICH MAKES THE SYRINGE UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495587 BD EMERALD 2ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811233

    Patients

    Seq Age Sex Outcome Treatment
    1