BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 238430 · Received September 1, 1999

    Report

    Report Number
    1056436-1999-00161
    Event Type
    Malfunction
    Date Received
    September 1, 1999
    Date of Event
    June 11, 1999
    Report Date
    August 31, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 08/31/1999, THE MANUFACTURER (MFR.) REC'D A MEDICAL DEVICE REPORTING ANNUAL USER FAICLITY REPORT FROM THE FACILITY THAT STATES THE FOLLOWING: THE INTRODUCER FOR THE DEVICE LINE SPLIT WHILE INTRODUCING IT INTO THE SITE. IT IS SUPPOSED TO SPLIT AND PULL OUT AS THE DEVICE IS PLACED. IT BROKE PRIOR TO THE DEVICE LINE BEING PLACED. ON 08/31/1999, THE MFR'S REP CONTACTED THE FACILITY'S RISK MGMT FOR ADD'L INFO (I.E., PT'S ID, DATE OF EVENT, IMPLANT PHYSICIAN'S NAME/ADDRESS/TELEPHONE NUMBER, IS THE DEVICE AVAILABLE TO BE RETURNED TO THE MFR, FOR ANALYSIS ETC.). THE FACILITY'S RISK MGMT REQUESTED FOR MFR FAX A BLANK PRODUCT COMPLAINT REPORT (PCR) FORM TO HER FOR COMPLETION. ON 09/01/1999, THE MFR REC'D PCR REPORT FROM THE FACILITY WITH THE INFO REQUESTED. THE REPORT ALSO STATES THAT THE DEVICE IN QUESTION WAS DISPOSED OF BY THE FACILITY. NO FURTHER DETAILS WERE PROVIDED. SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL, THE MFR'S INVESTIGATION OF THIS EVENT WILL BE LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA 14740

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other