MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-22 for ALCON VGFI INFUSION TUBING SET * 8065808002 manufactured by Alcon.
[3372214]
The white clamp on the fluid would not close all the way. Fluid was still able to pass through.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2928425 |
| MDR Report Key | 2928425 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-22 |
| Date of Event | 2012-12-21 |
| Report Date | 2013-01-22 |
| Date Reported to FDA | 2013-01-22 |
| Date Added to Maude | 2013-01-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON VGFI INFUSION TUBING SET |
| Generic Name | VITRECTOMY, INSTRUMENT CUTTER, INFUSION TUBING SET |
| Product Code | MLZ |
| Date Received | 2013-01-22 |
| Model Number | * |
| Catalog Number | 8065808002 |
| Lot Number | 1207211H-2011-09 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-22 |