FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4090340
·
Received September 15, 2014
Report
- Report Number
- 1416980-2014-31326
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- UNKNOWN MANUFACTURING FACILITY
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN UNKNOWN SET TUBING WAS LEAKING. THE REPORTER STATED THAT THE DEVICE WAS LEAKING IV FLUID. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568490 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | UNKNOWN MANUFACTURING FACILITY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |