FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3203090
·
Received July 2, 2013
Report
- Report Number
- 1416980-2013-17052
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 7, 2013
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- FPA
- PMA / PMN Number
- K964850
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE NOTED NO EVIDENCE OF PHYSICAL ABNORMALITY. FUNCTIONAL AND PRESSURE TESTING WERE PERFORMED AND NO EVIDENCE OF LEAK WAS IDENTIFIED. NO ROOT CAUSE WAS IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN EXTENSION SET LEAKED IN THE BOTTOM. THIS OCCURRED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302637 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |