BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNTAIN INFUSION CATHETER

    MDR report key: 1045202 · Received May 14, 2008

    Report

    Report Number
    1721504-2008-00031
    Event Type
    Other
    Date Received
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KRA
    Removal / Correction Number
    1721504-05/13/2008/006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CONCLUSIONS - OTHER: MERIT HAS DISCOVERED THAT A LIMITED NUMBER OF 4F FOUNTAIN CATHETERS WERE PACKAGED WITH OCCLUDING WIRES THAT WERE TOO LONG FOR THE CATHETER. AN OCCLUDING WIRE THAT IS TOO LONG FOR THE CATHETER WITH WHICH IT WILL BE USED WILL NOT OCCLUDE THE CATHETER APPROPRIATELY, ALLOWING THE WIRE TO EXIT, THE TIP OF THE CATHETER FURTHER THAN INTENDED. THIS MAY POSE A POTENTIAL RISK OF PT INJURY. ON MAY 13, 2008, MERIT DETERMINED THAT A RECALL IS NECESSARY TO PREVENT UNREASONABLE RISK TO PUBLIC HEALTH. ALL SUBSEQUENT INVESTIGATION RESULTS WILL BE SUBMITTED TO THE FDA IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    THIS IS TO INFORM YOU THAT MERIT MEDICAL SYSTEMS, INC IS VOLUNTARILY CONDUCTING A RECALL OF SPECIFIC LOTS OF FOUNTAIN CATHETERS MANUFACTURED BY MERIT MEDICAL SYSTEMS, INC. PLEASE NOTE THAT THERE HAS BEEN ONE ADVERSE EVENT REPORTED THAT IS ASSOCIATED WITH THIS RECALL; PLEASE REFER TO MDR 1721504-2008-00030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNTAIN INFUSION CATHETER CATHETERS, INFUSION, PERIPHERAL KRA MERIT MEDICAL SYSTEMS, INC. NA F496042

    Patients

    Seq Age Sex Outcome Treatment
    1