MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.
[80681657]
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
[80681658]
A customer reported that the cannula twisted off the syringe during a vitrectomy procedure. The product was replaced and the procedure was completed. There were no consequences to the patient. Additional information has been requested and received.
Patient Sequence No: 1, Text Type: D, B5
[132417701]
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. As the customer did not return the syringe associated with this complaint sample, a full evaluation could not be performed. Only the small parts tray was returned. Silicone oil covered the 25+ga cannula in returned condition. A viscous fluid control (vfc) tubing set and syringe from labstock was utilized to functionally test the 25+ga cannula. The cannula fully engaged and locked on the luer lock of the syringe. The plunger moved freely as it should during operation of the vfc with the cannula seated securely. No anomalies were observed during functional testing. The 25+ cannula did not twist off the luer lock of the syringe. The root cause of the complaint could not be established without the syringe complaint sample. It's possible the syringe caused or contributed to the reported event, however, this cannot be confirmed with the information available. When the sample was tested with the cannula, the sample functioned per specifications. No action will be taken for this occurrence, as the root cause is not known. Quality assurance will continue to monitor customer complaints and will take action for any future occurrences as is deemed necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2017-00601 |
| MDR Report Key | 6727752 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2017-07-20 |
| 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. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | 2017-07-20 |
| Returned To Mfg | 2017-07-25 |
| Model Number | NA |
| Catalog Number | 8065750957 |
| Lot Number | 1996466H |
| ID Number | NA |
| Device Expiration Date | 2019-02-28 |
| 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 | 2017-07-20 |