MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.
[124674638]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. A product sample has been received by the manufacturer and it is awaiting evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124674639]
A materials coordinator reported when surgeon "hit the foot pedal to inject the silicone", the cannula disconnect and the silicone spilled during a vitrectomy procedure. The product was replaced and the procedure was completed with no harm to the patient. No additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2018-00247 |
| MDR Report Key | 7992492 |
| Date Received | 2018-10-22 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-09-28 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-01-17 |
| Date Added to Maude | 2018-10-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-10-19 |
| Model Number | NA |
| Catalog Number | 8065750957 |
| Lot Number | 2108641H |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-22 |