BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML ENTERAL SYRINGE, BULK NON-STERILE

    MDR report key: 6753775 · Received July 31, 2017

    Report

    Report Number
    1911916-2017-00109
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    May 23, 2017
    Report Date
    July 24, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KNT
    PMA / PMN Number
    K112434
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE UNIT WAS RECEIVED FOR EVALUATION. OUR QUALITY ENGINEER MICROSCOPICALLY INSPECTED THE RETURNED UNIT AND CONFIRMED THAT FOREIGN MATTER WAS EMBEDDED INTO THE SYRINGE BARREL. THE FOREIGN WAS IDENTIFIED AS OVER-PROCESSED POLYPROPYLENE. A COMPLAINT HISTORY CHECK REVEALED NO SIMILAR INCIDENTS FOR REPORTED LOT NUMBER 6201790. CONCLUSION: BD WAS ABLE TO CONFIRM THE REPORTED INCIDENT. THE ENGINEER CONCLUDES THAT THE FOREIGN WAS LIKELY INTRODUCED DURING THE MOLDING PROCESS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A REDDISH-BROWN DISCOLORATION INSIDE THE SYRINGE BARREL OF THE 20ML BD ENTERAL SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536254 BD 20ML ENTERAL SYRINGE, BULK NON-STERILE ENTERAL SYRINGE KNT BD MEDICAL (BD WEST) MEDICAL SURGICAL 6201790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other