inforMED
MalfunctionMSD

ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM

Received Jun 23, 2026 · Event occurred May 28, 2026

Report 9680794-2026-00475 · MDR key 25593705

Device

Generic name

Catheter, Hemodialysis, Impla

Catalog number

CS-15242-SP

Lot number

33F24A0271

Product problems

  • Crack
  • Fluid/Blood Leak

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, THAT AN INDWELLING CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER (CHDC), ORIGINALLY INSERTED ON (B)(6) 2026, EXHIBITED CRACKING AT THE LUER HUB/FITTING ACCOMPANIED BY BLOOD OOZING FROM THE AFFECTED AREA. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.