BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL

    MDR report key: 8312107 · Received February 6, 2019

    Report

    Report Number
    9616657-2019-00114
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 11, 2019
    Report Date
    March 4, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: COMPLAINT TRENDING REVIEW OF THE LOT FOR THIS ISSUE REVEALS THIS IS THE FIRST COMPLAINT FOR FOREIGN MATTER ON LOT NUMBER 8242797, PRODUCT CODE 306572. THE NON-CONFORMANCE'S WERE REVIEWED FOR THIS BATCH AND THERE WAS NO RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH FOR THIS DEFECT. THE SAMPLE RECEIVED CONFIRMED FOREIGN MATTER PRESENT IN THE SAMPLE. IT IS POSSIBLE THAT THE FOREIGN MATTER IS A RESULT OF PARTICLES BUILD UP (POLYPROPYLENE) ON THE EQUIPMENT DUE TO RAIL AND BARREL CONTACT, THEREFORE CAUSING PARTICLES TO ADHERE TO THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106619 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL SYRINGE FMF BECTON, DICKINSON AND CO. 8242797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other