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 2017-06-27 for 3/16" (4.8MM) X 6' (1.8M) 0036480 manufactured by Consolidated Medical Equipment Company.
[78590538]
The reported 0036480- surgical tubing 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
[78590539]
The distributor in (b)(6) reported that during inspection of incoming products, one 3/16" x 6' surgical tubing was 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00155 |
| MDR Report Key | 6671975 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-06-27 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-05-30 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2016-09-21 |
| Date Added to Maude | 2017-06-27 |
| 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 | 3/16" (4.8MM) X 6' (1.8M) |
| Generic Name | SURGICAL TUBING |
| Product Code | BYY |
| Date Received | 2017-06-27 |
| Returned To Mfg | 2017-08-14 |
| Catalog Number | 0036480 |
| Lot Number | 201609215 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Address | AVE. ALEJANDRA DUMAS NO. 11321 COMPLEJO INDUCTRIAL CHIHUAHUA CHIHUAHUA, MEXICA NY 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |