|
|
| Catalog Number 8065-808-01 |
| Event Date 06/08/1994 |
|
Patient Outcome
Hospitalization;
Required Intervention
|
|
Event Description
|
Gravity flow irrigation (gfi) tubing blow-out at filter/spike junction.
Bss plus was dripping on floor and air entered eye.
Physician is concerned about possible damage.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | ALCON GFI TUBING |
|---|
| Type of Device | GRAVITY FLOW IRRIGATION TUBING |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| ALCON LAB INC. |
| 6201 s. frreway |
| ft. worth TX 76134 |
|
| Manufacturer (Section D) |
| ALCON LAB INC. |
| 6201 s. frreway |
| ft. worth TX 76134 |
|
| Device Event Key | 21264 |
|---|
| MDR Report Key | 21275 |
|---|
| Event Key | 19580 |
|---|
| Report Number | 21275 |
|---|
| Device Sequence Number | 1 |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
Nurse
|
| Type of Report
| Initial |
|---|
| Report Date |
06/17/1994 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 01/05/1995 |
|---|
| Is This An Adverse Event Report? |
Yes
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | 8065-808-01 |
|---|
| Device LOT Number | 92419 |
|---|
| Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
|---|
| Date Returned to Manufacturer | 06/08/1994 |
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Distributor Facility Aware Date | 06/08/1994 |
|---|
| Event Location |
Hospital
|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
|
|
Database last updated on February 28, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
