MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-02-22 for 1/4" (6.4MM) X 6' (1.8MM) W/M&F CO 0037860 manufactured by Consolidated Medical Equipment.
[100903768]
To date, the reported device has not been returned to conmed for evaluation. Should the device be returned, this complaint will be reassessed. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product. The products released for distribution were found to have met all specifications prior to shipment. A two-year historical complaint review revealed (b)(4) prior complaints for this device family and failure mode. In this same timeframe, (b)(4) units have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent. A risk analysis was performed and deemed acceptable. This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation. There was no patient involvement. As with all medical devices, examination of the product occurs multiple times prior to use. Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact. The instructions for use (ifu) provides the following warning. If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately. This incident type will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[100903769]
The distributor in (b)(6) rejected one 0037860 surgical tubing due to an "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. 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 | 3007305485-2018-00036 |
| MDR Report Key | 7288861 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-02-22 |
| Date of Report | 2018-04-30 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2017-02-02 |
| Date Added to Maude | 2018-02-22 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| 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' (1.8MM) W/M&F CO |
| Generic Name | SURGICAL TUBING |
| Product Code | BYY |
| Date Received | 2018-02-22 |
| Returned To Mfg | 2018-03-27 |
| Model Number | 0037860 |
| Catalog Number | 0037860 |
| Lot Number | 201702024 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-22 |