MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-11 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.
[57453785]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57453786]
An operating room assistant reported that the needle was observed coming off the syringe during a procedure. The product was replaced and the procedure was completed. Additional information and product sample have been requested.
Patient Sequence No: 1, Text Type: D, B5
[61218139]
Supplemental medical device report (smdr) # 01 is being filed to correct the date on the initial report, filed earlier. Incorrect date of (b)(6) 2016 is being corrected to (b)(6) 2016. A product sample was received and it is awaiting evaluation. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64749930]
The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue. The device history record shows the product was released per specifications. A used viscous fluid control (vfc) assembly was returned and visually inspected. The vfc tubing set was connected to a glass syringe with silicone oil inside the syringe and around the 25+ gauge infusion cannula. The glass syringe was identified as a non-compatible 10 millimeter syringe from a different manufacturer. The customer's usage of a non-compatible component resulted in a potentially hazardous condition for the patient. The directions-for-use (dfu) clearly states the manufacturing site assumes no responsibility for complications that may arise as a result of improper usage of any part of the product. Use of disposables other than those of the manufacturer's may affect system performance and create potential hazards, such as in this case. After a thorough investigation of this complaint, it has been determined that no action will be taken at this time. The customer did not follow the dfu and utilized a non-compatible component. Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2016-01300 |
| MDR Report Key | 6017805 |
| Date Received | 2016-10-11 |
| Date of Report | 2017-01-11 |
| Date Mfgr Received | 2017-01-06 |
| Device Manufacturer Date | 2016-04-05 |
| Date Added to Maude | 2016-10-11 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | 3 |
| Brand Name | VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2016-10-11 |
| Returned To Mfg | 2016-11-21 |
| Model Number | NA |
| Catalog Number | 8065750957 |
| Lot Number | 1866209H |
| ID Number | NA |
| Device Expiration Date | 2018-03-31 |
| 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 | 1. Other | 2016-10-11 |