MalfunctionMPB
HEMO-CATH®
Received Jun 11, 2026 · Event occurred May 25, 2026
Report 2518902-2026-00040 · MDR key 25470247
Device
Generic name
Hemo-cath St Silicone Double Lumen Catheter
Manufacturer
Medical Components, Inc.Model number
SDL138ECatalog number
SDL138E
Lot number
MRNF730
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OUR INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
A HOLE WAS FOUND IN THE VENOUS ACCESS SITE AFTER CLAMPING, RESULTING IN LEAKS DURING DIALYSIS.