FDA Adverse Event
Malfunction
Summary report: N
SET, ADMINISTRATION, INTRAVASCULAR
MDR report key: 4112226
·
Received September 23, 2014
Report
- Report Number
- 1416980-2014-32937
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Report Date
- August 29, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN UNKNOWN ACCESS ONE-LINK SET HAD NO FLOW OF AN UNKNOWN MEDICATION. AFTER THIS OCCURRED THE LINE WAS RE-PRIMED AND INFUSION WAS COMPLETED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591591 | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |