BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRE-FILLED FLUSH SYRINGE

    MDR report key: 1649157 · Received March 26, 2010

    Report

    Report Number
    1057300-2010-00007
    Event Type
    Other
    Date Received
    March 26, 2010
    Manufacturer
    AMSINO MEDICAL USA
    Product Code
    FOZ
    PMA / PMN Number
    K990308
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE MEDICAL DEVICE FACILITY RESPONSE TO THE (B)(4). THE EVENT WAS NOT REPORTED TO AMU. THE MEDWATCH INDICATES THAT NO CAUSE COULD BE DETERMINED FOR THE EVENT AND THERE WAS NO INDICATION THAT THE PRE-FILLED FLUSH SYRINGE USED 90 MINUTES EARLIER WAS A CONTRIBUTOR EITHER. THE SOURCE OF HEPARIN FOR AMU PRODUCT REMAINS THE SAME AS IN (B)(4). THE BATCH RECORD WAS REVIEWED (ATTACHED) AND THERE WERE NO MFG EXCEPTIONS NOTED, THAT COULD HAVE BEEN A CONTRIBUTOR TO THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRE-FILLED FLUSH SYRINGE FOZ AMSINO MEDICAL USA KH02775

    Patients

    Seq Age Sex Outcome Treatment
    1