BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS DEVICE

    MDR report key: 39619 · Received September 6, 1996

    Report

    Report Number
    1219454-1996-00397
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 8, 1996
    Report Date
    September 6, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY HAD RECEIVED THE DEVICE IN A CARDBOARD BOX WHICH WAS NOT DAMAGED; HOWEVER, THE DEVICE BOX INSIDE WAS DAMAGED AND SMASHED -INDICATING THAT IT WAS SHIPPED FROM THE MFR IN THAT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS DEVICE VASCULAR ACCESS DEVCIE LJT STRATO/INFUSAID, INC. NA 13085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other