FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4929203
·
Received July 21, 2015
Report
- Report Number
- 1416980-2015-29640
- Event Type
- Malfunction
- Date Received
- July 21, 2015
- Date of Event
- July 3, 2015
- Report Date
- July 7, 2015
- Manufacturer
- BAXTER HEALTHCARE SA (SINGAPORE BRANCH)
- Product Code
- FPA
- PMA / PMN Number
- K112893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VENTED SOLUTION SET LEAKED FROM BETWEEN THE TUBING AND VALVE. PATIENT INVOLVEMENT AND THE STEP OF SETUP OR THERAPY DURING WHICH THIS OCCURRED ARE UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471589 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE SA (SINGAPORE BRANCH) | SR14G16021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |