MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-09-13 for 1/4" (6.4MM) X 6' (1.8M) 0036280 manufactured by Consolidated Medical Equipment.
[86087771]
The reported device is expected to be returned for evaluation. A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[86087772]
The distributor in (b)(4) rejected one 0036280 surgical tubing with "insufficient heatseal" during incoming inspection. In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user. The report is raised on the basis of a device malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00206 |
| MDR Report Key | 6860867 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-12 |
| Date Mfgr Received | 2017-08-21 |
| Device Manufacturer Date | 2016-12-05 |
| Date Added to Maude | 2017-09-13 |
| 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 | LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| 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 | 2017-09-13 |
| Catalog Number | 0036280 |
| Lot Number | 201612055 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, CHIHUAHUA 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-13 |