BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLVE LOCKING DRAINAGE CATHETERS

    MDR report key: 2062392 · Received March 18, 2011

    Report

    Report Number
    1628221-2011-00015
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVAL. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE SUSPECT DEVICE. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. THE CUSTOMER HAS NOT INDICATED IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSION: A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CATHETER WAS USED AS A GASTRIC J (FEEDING) TUBE. THE CATHETER BROKE AT THE MARKER BAND AFTER BEING IN PLACE SINCE (B)(6), 2010. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE DEVICE. NO HARM OR INJURY WAS REPORTED. THIS PARTICULAR CUSTOMER REPORTED A SIMILAR EVENT ON (B)(6) 2010, FOR THE SAME PT. REFERENCE REPORT 1628221-2010-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLVE LOCKING DRAINAGE CATHETERS CATHETER, IRRIGATION FGE MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1