ONESTEP
Received Mar 9, 2026 · Event occurred Oct 31, 2025
Report 1721504-2026-00905 · MDR key 24550807
Device
Generic name
Single Use Instrument Tray
Manufacturer
Merit Medical Systems, Inc.Catalog number
SPPT-5F-7L
Product problems
- Fracture
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem
ACCOUNT REPORTED THE ONE-STEP 5 FRENCH 7C 8MM CATHETER WAS BEING USED DURING A RADIOLOGICAL PROCEDURE. THE PROVIDER NOTED THAT THE CATHETER WAS NOT DRAINING DURING A ROUTINE THERAPEUTIC PARACENTESIS. THE DOCTOR REMOVED THE CATHETER AND DISCOVERED THAT THE TIP OF THE CATHETER WAS NO LONGER PRESENT. ULTRASOUND SHOWED THAT THE TIP WAS RETAINED AND PRESENT IN THE SUBCUTANEOUS TISSUE OF THE RIGHT LOWER QUADRANT OF THE ABDOMEN. SURGERY WAS CONSULTED AND SCHEDULED. UNFORTUNATELY, NEITHER THE PACKAGING OR THE CATHETER ITSELF WAS SAVED BY THE DIAGNOSTIC RADIOLOGY STAFF.