FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 2970391
·
Received February 20, 2013
Report
- Report Number
- 1416980-2013-04281
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Report Date
- February 4, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K120443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION: A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN UNKNOWN NUMBER OF POWER INJECTABLE MICROBORE NON-DEHP CATHETER EXTENSION SET WITH NEUTRAL LAD WERE OBSERVED TO HAVE A NO FLOW AFTER THE SETS WERE CONNECTED TO A SYRINGE OR TUBING. THIS MALFUNCTION WAS REPORTED TO OCCUR DURING PATIENT INFUSION; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73578 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |