FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3093533
·
Received May 6, 2013
Report
- Report Number
- 1416980-2013-11379
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 11, 2013
- Manufacturer
- BAXTER HEALTHCARE - MALTA
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER (B)(4) THAT A SOLUTION ADMINISTRATION SET HAD A LEAK BETWEEN THE TUBE AND THE Y-SITE. THIS CONDITION OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197235 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - MALTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |