MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-07-18 for 1/4" (6.4MM) X 6' (1.8M) 0036280 manufactured by Conmed Corporation.
[80308700]
The reported (b)(4)- surgical tubing sets are expected to be returned to conmed corporation for evaluation. A supplemental and final report will be filed upon the completion of the product evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[80308701]
The distributor in (b)(6) reported that during inspection of incoming products, two surgical tube sets were discovered with "insufficient heatseal". In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user. This report is raise as a product malfunction with potential for patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00170 |
| MDR Report Key | 6721493 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-07-18 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2016-10-21 |
| Date Added to Maude | 2017-07-18 |
| 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. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1/4" (6.4MM) X 6' (1.8M) |
| Generic Name | SURGICAL TUBING |
| Product Code | BYY |
| Date Received | 2017-07-18 |
| Returned To Mfg | 2017-09-11 |
| Catalog Number | 0036280 |
| Lot Number | 201610215 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-18 |