BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 7229237 · Received January 30, 2018

    Report

    Report Number
    1718873-2018-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 30, 2018
    Manufacturer
    UTAH MEDICAL PRODUCTS INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THESE TWO EVENTS ARE BEING REPORTED PER THE ASR REPORTING REQUIREMENTS UNDER EXEMPTION NUMBER 2011004. ONE OF THE CATHETERS WAS A SINGLE LUMEN 3.5 FRENCH SILICONE CATHETER CATALOG NUMBER 4173505 AND 2ND CATHETER WAS A 5.0 FRENCH DUAL LUMEN CATHETER CATALOG NUMBER 4275005. BOTH CATHETERS HAD INDICATIONS THAT THE TUBING HAD BEEN DAMAGED (CUT OR NICKED) PRIOR TO THE TUBING SEVER. IN BOTH CASES THE TUBING SEGMENT SEVERED FROM THE CATHETER WAS ROUTINELY REMOVED WITHOUT PATIENT IMPACT. BOTH CATHETERS MET THE TUBING STRENGTH SPECIFICATIONS WHEN TESTED AFTER RETURN TO UTMD.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 REPORTED EVENTS WHICH WERE REPORTED OVER A 3 MONTH TIME PERIOD. ON BOTH EVENTS, CATHETER TUBING SEVERED WHILE THE CATHETER WAS BEING REMOVED FROM THE PATIENT. IN BOTH CASES THE SEGMENT WHICH WAS SEVERED FROM THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70772 UMBILI-CATH UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS INC. 3.5 FR & 5.0 FR

    Patients

    Seq Age Sex Outcome Treatment
    1