FDA Adverse Event
Malfunction
Summary report: N
CLEARLINK/DUO-VENT
MDR report key: 24220781
·
Received January 30, 2026
Report
- Report Number
- 24220781
- Event Type
- Malfunction
- Date Received
- January 30, 2026
- Date of Event
- October 28, 2025
- Report Date
- January 20, 2026
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PARTIAL CHEMO DISTRIBUTED TO PATIENT. PARTIAL CHEMO SPILL DUE TO FAULTY PRE PRIMED CHEMO TUBING. SPILL OF CHEMO WENT UNNOTICED BY PATIENT AND RNS AS IT OCCURRED DUE TO FAULTY WHITE CONNECTION PIECE FROM PHARMACY AND WAS ENTIRELY CONTAINED IN TRASHCAN BELOW PUMP. APPROPRIATE PRECAUTIONS TAKEN TO CLEAN UP WITH CHEMO SPILL KIT PER PROTOCOL. PRODUCT# 2R8875, LOT: (10) R25B22116, EXP:2027-02-23. NO PATIENT OR STAFF HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286036 | CLEARLINK/DUO-VENT | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORPORATION | 2R8875 | R25B22116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |