BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8724637 · Received June 21, 2019

    Report

    Report Number
    3007795799-2019-00003
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 21, 2019
    Manufacturer
    INTERRAD MEDICAL
    Product Code
    OKC
    UDI-DI
    00865382000242
    PMA / PMN Number
    K180769
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 18TH, 2019, INTERRAD MEDICAL RECEIVED A USER FACILITY REPORT REGARDING A 7F SECURACATH DEVICE OCCLUDING FLOW WHEN PLACED ON A BARD 7F DL HICKMAN CATHETER. INTERRAD MEDICAL REACHED OUT TO THE USER FACILITY AND WAS ABLE TO HAVE THE DEVICE RETURNED FOR EVALUATION. THE EVALUATION INCLUDED A REVIEW OF INTERNAL DOCUMENTS, PHYSICAL EXAMINATION OF THE DEVICE AND TYPE OF CATHETER INVOLVED. THERE WERE NO CONCERNS IDENTIFIED WITH THE INTERNAL DOCUMENT REVIEW AND THERE WERE NO INDICATIONS OF ANY MANUFACTURING DEFECTS OR ANOMALIES WITH THE SECURACATH DEVICE. THE BARD 7F DL HICKMAN CATHETER WAS EVALUATED AND FOUND TO HAVE 2 SIGNIFICANTLY DIFFERENT CATHETER OUTER DIAMETERS (ODS). THE DISTAL SEGMENT OF THE CATHETER WAS APPROXIMATELY 7F (2.3MM) OD, BUT THE PROXIMAL SEGMENT NEAR THE CUFF WAS 10.2F (3.4MM) OD. THE CORRECT SIZE SECURACATH DEVICE FOR THE 7F HICKMAN CATHETER PROXIMAL TO THE CUFF WOULD BE A 10F SECURACATH DEVICE. PER THE SECURACATH INSTRUCTIONS FOR USE, "SELECT THE APPROPRIATE SIZE SECURACATH DEVICE TO MATCH THE CATHETER DIAMETER. IF CATHETER IS LABELED WITH HALF FRENCH SIZE, USE THE CLOSEST SMALLER SIZE SECURACATH". THIS WAS NOT A MALFUNCTION OF THE SECURACATH DEVICE AND NO INJURY WAS REPORTED. THIS IS BEING REPORTED TO PROVIDE A RESPONSE TO THE USER FACILITY REPORT OF A SECURACATH DEVICE MALFUNCTION (MEDWATCH REPORT #(B)(4)). THE CONCLUSION OF INTERRAD MEDICAL'S EVALUATION IS THAT THERE WAS NOT A MALFUNCTION OF THE DEVICE BUT THE CAUSE OF THE ISSUE WAS THE INCORRECT SECURACATH SIZE BEING SELECTED DUE TO THE LOCATION WHERE THE SECURACATH WAS BEING PLACED ON THE CATHETER. THE BARD 7F DL HICKMAN HAS A LARGER OD PROXIMAL TO THE CUFF WHERE THE SECURACATH WOULD BE PLACED THEN THE LABELED FRENCH SIZE INDICATES. THE PACKAGE LABEL FOR THIS CATHETER DOES INDICATE THE DIFFERENT DIMENSIONS IN MILLIMETERS FOR THE LARGER AND SMALLER ODS IN A DIAGRAM ON THE PACKAGE LABEL.

    Description of Event or Problem · 1

    AFTER INSERTING A BARD 7F DL HICKMAN CATHETER A 7F SECURACATH DEVICE WAS PLACED AND NOTED THE LINES WERE OCCLUDED. THE SECURACATH DEVICE WAS REMOVED WITHOUT FURTHER INCIDENT AND SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517804 SECURACATH SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE OKC INTERRAD MEDICAL SCR-01 A1850 00865382000242

    Patients

    Seq Age Sex Outcome Treatment
    1