MalfunctionMPB
ARROW 2 LUMEN BLUE HIGH VOLUME WITH BLUE FLEXTIP ARROWGUARD
Received Jun 12, 2025 · Event occurred Apr 29, 2025
Report 22193586 · MDR key 22193586
Device
Generic name
Catheter, Hemodialysis, Non-implanted
Manufacturer
Teleflex IncorporatedProduct problems
- Detachment of Device or Device Component
Patient
59 YR · 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.