BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRE-FILLED FLUSH SYRINGE

    MDR report key: 1647977 · Received March 26, 2010

    Report

    Report Number
    1057300-2010-00002
    Event Type
    Death
    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). ALSO, AMU WAS UNAWARE THAT ON FEB 4, 2009, (B) (4) REQUESTED THIS HEPARIN INFO FROM AMSINO MED USA ON THIS BATCH. AMU WAS NOT INFORMED AT THAT TIME OF THE DEATH ON THE MEDWATCH EVENT. (B) (4). THE HEPARIN PRE-FILLED FLUSH SYRINGE WAS NOT THE CAUSE OF THE DEATH.

    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 KH02517

    Patients

    Seq Age Sex Outcome Treatment
    1