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 2017-05-22 for 1/4" X 10' SUCTION TUBING 0036290 manufactured by Conmed Corporation.
[75693273]
Device not returned by distributor.
Patient Sequence No: 1, Text Type: N, H10
[75693274]
As reported by the distributor in (b)(4), one(1) 0036290 1/4" x 10' suction tubing package was discovered to have an "insufficient heatseal or blister pack. " there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user. As of this filing, the device has not been returned to conmed. Once received, the evaluation will be completed and a supplemental and final will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00114 |
| MDR Report Key | 6582619 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-05-22 |
| Date of Report | 2017-07-17 |
| Date Mfgr Received | 2017-06-20 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2017-05-22 |
| 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 | MS. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1/4" X 10' SUCTION TUBING |
| Generic Name | TUBE, ASPIRATING, FLEXIBLE, CONNECTING |
| Product Code | BYY |
| Date Received | 2017-05-22 |
| Returned To Mfg | 2017-06-06 |
| Catalog Number | 0036290 |
| Lot Number | 201610075 |
| 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 | 2017-05-22 |