FDA Adverse Event
No answer provided
Summary report: N
CONTINU-FLO DUO-VENT SPIKE 10 DROPS/ML TUBING
MDR report key: 16528947
·
Received March 13, 2023
Report
- Report Number
- 16528947
- Event Type
- No answer provided
- Date Received
- March 13, 2023
- Date of Event
- December 8, 2022
- Report Date
- February 27, 2023
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SEVERAL BAXTER CONTINU-FLO SOLUTION SETS WITH DUO-VENT SPIKE 10 DROPS/ML TUBING KINKED AFTER SPIKING WITH LACTATED RINGERS AND PROPOFOL. LOT NUMBERS (10)R22I1031 AND (10)R22I03086. MANUFACTURER RESPONSE FOR IV TUBING, IV TUBING DUO-VENT SPIKE 10 DROPS/ML TUBING (PER SITE REPORTER). ONGOING ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514454 | CONTINU-FLO DUO-VENT SPIKE 10 DROPS/ML TUBING | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORPORATION | R22I1031, R22I03086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |