FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3931005
·
Received July 13, 2014
Report
- Report Number
- 1416980-2014-22483
- Event Type
- Malfunction
- Date Received
- July 13, 2014
- Report Date
- June 18, 2014
- Manufacturer
- BAXTER HEALTHCARE - MALTA
- Product Code
- BRZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A Y TYPE BLOOD SET LEAKED FROM RIGHT UNDER ITS DRIP CHAMBER. THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409048 | ACCESS | SET, BLOOD TRANSFUSION | BRZ | BAXTER HEALTHCARE - MALTA | 14B03V463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |