FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 4141573
·
Received October 4, 2014
Report
- Report Number
- 1416980-2014-34517
- Event Type
- Malfunction
- Date Received
- October 4, 2014
- Report Date
- September 9, 2014
- Manufacturer
- BAXTER HEALTHCARE - MALTA
- Product Code
- KPE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A 500 ML EVA TPN BAG LEAKED. THE REPORTER STATED THAT THE BAG LEAKED FROM THE SEAM AFTER FILLING. 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 |
|---|---|---|---|---|---|---|---|
| 621331 | IVT DISPOSABLE | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - MALTA | 14D03V209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |