HIGH PRESSURE TUBING
Received Aug 6, 2025 · Event occurred Jun 18, 2025
Report 1721504-2025-00239 · MDR key 22731601
Device
Generic name
High Pressure Tubing
Manufacturer
Merit Medical Systems, Inc.Catalog number
HPF720E/B
Lot number
I3094977
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT IS CONFIRMED. ROOT CAUSE IS ATTRIBUTED TO ROUGH HANDLING BY THE USER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT WERE IDENTIFIED.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THE THREAD ON THE TUBING WAS BROKEN AND CAME OFF INSIDE THE COBRA PROBE. THE DEVICE WAS REPLACED AND PROCEDURE WAS CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.