BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 24616102 · Received March 17, 2026

    Report

    Report Number
    24616102
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 9, 2026
    Manufacturer
    INTERRAD MEDICAL, INC
    Product Code
    OKC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE REMOVED A SINGLE-LUMEN PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE IN AN OUTPATIENT TODAY THAT RUPTURED AT THE 8 CM MARK DURING A CT SCAN WITH CONTRAST. IT INFILTRATED 2 SCANS WORTH OF CONTRAST INTO THE PATIENT'S ARM. THE LINE WAS PLACED BY THE [REDACTED] PICC TEAM IN [REDACTED]. WHILE THE FAILURE DIDN'T HAPPEN INSIDE THE SECURACATH, THE LINE IS ALSO IMPRESSIVELY DEFORMED WHERE THE WITHIN THE SECURACATH COMPRESSION AREA. THE PATIENT ARRIVED IN THE CT DEPARTMENT AT [REDACTED] FOR A CT SCAN WITH AND WITHOUT CONTRAST. THE PATIENT PRESENTED WITH A POWER PICC THAT HAD BEEN IN PLACE FOR ABOUT TWO MONTHS. I FLUSHED THE PICC WITHOUT DIFFICULTY, CONNECTED THE CONTRAST INJECTOR, AND ADMINISTERED THE CONTRAST BOLUS. AFTER COMPLETING THE DIAGNOSTIC SCAN, I OBSERVED THAT NO CONTRAST WAS VISIBLE IN THE PATIENT¿S VESSELS OR HEART ON IMAGING. A BEDSIDE ASSESSMENT SHOWED THE PICC APPEARED EXTERNALLY INTACT, WITH NO VISIBLE CONTRAST LEAKAGE ON THE TABLE OR FLOOR. I OBTAINED AN AP CHEST SCOUT IMAGE, WHICH CLEARLY DEMONSTRATED THAT THE CONTRAST BOLUS HAD EXTRAVASATED INTO THE PATIENT¿S ARM, CONFIRMING PICC FAILURE. I NOTIFIED NURSING AND RADIOLOGY. ICE AND ELEVATION WERE APPLIED, AND THE PATIENT WAS INSTRUCTED ON SIGNS AND SYMPTOMS OF CONTRAST EXTRAVASATION. DR. ASSESSED THE PATIENT AND RECOMMENDED REMOVING THE PICC TO ENSURE THE ENTIRE CATHETER WAS INTACT. RN CONTACTED THE PROVIDER AND OBTAINED A VERBAL ORDER TO DISCONTINUE THE PICC. RN REMOVED THE LINE AND CONFIRMED THAT THE FULL LENGTH OF THE PICC WAS RETRIEVED FROM THE PATIENT¿S VASCULATURE. I THEN PLACED A 20-GAUGE PERIPHERAL IV IN THE PATIENT¿S LEFT WRIST, AND BOTH THE CT AND MRI EXAMS WERE COMPLETED WITHOUT ADDITIONAL ISSUES. THE PATIENT WAS DISCHARGED HOME. MANUFACTURER RESPONSE FOR IMPLANTED SUBCUTANEOUS SECUREMENT CATHETER, SECURACATH (PER SITE REPORTER). THANK YOU FOR REACHING OUT WITH THE CASE INFORMATION. INTERRAD MEDICAL HAS INITIATED ISSUE-[REDACTED] FOR THIS INVESTIGATION AND WOULD LIKE THE UNIT RETURNED TO OUR FACILITY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684744 SECURACATH IMPLANTED SUBCUTANEOUS SECUREMENT CATHETER OKC INTERRAD MEDICAL, INC 4F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other