BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT INFUSION SET WITH Y-SITE

    MDR report key: 252770 · Received December 6, 1999

    Report

    Report Number
    1056436-1999-00205
    Event Type
    Malfunction
    Date Received
    December 6, 1999
    Date of Event
    November 2, 1999
    Report Date
    November 9, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/09/1999, THE FACILITY'S PURCHASING CLERK INFORMED THE MFR'S REP VIA TELEPHONE THEY HAD EXPERIENCED A PROBLEM WITH THE DEVICE IN QUESTION BUT SHE DID NOT HAVE ALL THE INFO ON HAND. ON 11/10/1999, THE MFR REC'D A REPORT VIA A FAX FROM THE FACILITY THAT STATES THE FOLLOWING: THIS WAS DISCOVERED DURING FLUSHING THE LINE SETTING UP - NOT ACTUALLY USED ON THE PT. ON 11/10/1999, THE MFR'S REP CONTACTED THE FACILITY'S PURCHASING CLERK TO CLARIFY THE REPORT (WHAT PROBLEM WAS DISCOVERED). THE FACILITY'S PURCHASING CLERK STATED THAT THE CATHETER LUMEN WAS NOT PATENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT INFUSION SET WITH Y-SITE INFUSION SET WITH Y-SITE 22GA X .75" LJT HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other