MalfunctionMPB
ARROW 2 LUMEN BLUE HIGH VOLUME WITH BLUE FLEXTIP
Received Jun 16, 2025 · Event occurred Apr 29, 2025
Report 22211364 · MDR key 22211364
Device
Generic name
Catheter, Hemodialysis, Non-implanted
Manufacturer
Teleflex Medical LlcProduct problems
- Device Slipped
- Detachment of Device or Device Component
Patient
1 MO · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HD [HEMODIALYSIS] CATHETER WHITE SECUREMENT DEVICE WAS SUTURED TO PATIENT¿S SKIN; CATHETER CAME OUT OF SECUREMENT DEVICE AND OUT OF PATIENT. THE SUTURES WERE PLACED AT THE TRIANGULAR JUNCTURE HUB WITH INTEGRAL ROTATING SUTURE WINGS, AND THE BLUE PLASTIC PIECE WAS ABLE TO SLIP OUT OF THAT. THIS SAME EXACT ISSUE OCCURRED WITH 2 DIFFERENT PATIENT¿S AND THE LINES WERE PLACED BY TWO DIFFERENT PROVIDERS.