FDA Adverse Event
Malfunction
Summary report: N
ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
MDR report key: 25222410
·
Received May 19, 2026
Report
- Report Number
- 9680794-2026-00393
- Event Type
- Malfunction
- Date Received
- May 19, 2026
- Date of Event
- December 31, 2025
- Report Date
- April 27, 2026
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- PPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT ON (B)(6) 2025, "THE PATIENT IDENTIFIED THAT THE CATHETER'S LUER HUB WAS CRACKED. FOLLOWING CONSULTATION, THE AFFECTED LUER HUB WAS REPLACED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514588 | ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM | CATHETER, HEMODIALYSIS, IMPLA | PPO | ARROW INTERNATIONAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |