BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 181062 · Received August 5, 1998

    Report

    Report Number
    1220923-1998-00070
    Event Type
    Injury
    Date Received
    August 5, 1998
    Date of Event
    July 6, 1998
    Report Date
    July 7, 1998
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 07/07/1998, THE FACILITY'S DIRECTOR, PURCHASING INFORMED THE MFR'S REP OF THE FOLLOWING: THE DEVICE CATHETER SHEARED. THE DEVICE BODY WAS EXPLANTED ON 07/06/1998; HOWEVER, THE SEGMENT OF CATHETER HAD NOT BEEN REMOVED AT THE TIME OF THIS REPORT. THE MFR'S REP ASKED WHEN THE SEGMENT OF CATHETER WOULD BE RETRIEVED. THE FACILITY'S DIRECTOR, PURCHASING STATED THAT IT COULD BE REMOVED TODAY (07/07/1998), BUT SHE WAS NOT SURE. THE MFR'S REP REQUESTED THAT THE DEVICE AND SEGMENT OF CATHETER BE RETURNED AT THE SAME TIME TO ENABLE THE MFR TO PERFORM A MORE ACCURATE/COMPLETE ANALYSIS OF THE DEVICE. THE FACILITY'S DIRECTOR, PURCHASING STATED THAT SHE WOULD ATTEMPT TO FIND OUT WHEN THE CATHETER SEGMENT WOULD BE RETRIEVED SO BOTH THE DEVICE AND CATHETER CAN BE ANALYZED AT THE SAME TIME AND WOULD CONTACT THE MFR'S REP WITH THE INFORMATION. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID, INC. NA 13898

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention