BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRE-FILLED FLUSH SYRINGE

    MDR report key: 1649159 · Received March 26, 2010

    Report

    Report Number
    1057300-2010-00006
    Event Type
    Other
    Date Received
    March 26, 2010
    Manufacturer
    AMSINO MEDICAL USA
    Product Code
    FOZ
    PMA / PMN Number
    K984590
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE MEDICAL DEVICE FACILITY RESPONSE TO THE (B)(4). THE BROKEN TIP OF SYRINGE (THE LUER) DEFECT HAS BEEN INVESTIGATED REFERENCE CORRECTED ACTION DETAILED IN THE AMU RESPONSE TO THE FDA 483, NOTED IN JANUARY 2010. THE BATCH RECORD WAS REVIEWED AS WELL AND THERE WERE NO MFG EXCEPTIONS NOTED THAT COULD HAVE CONTRIBUTED TO THIS DEFECT.

    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 KH02797

    Patients

    Seq Age Sex Outcome Treatment
    1