MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-03-06 for POOLE SUCTION INSTRUMENT 50/C 0035040 manufactured by Conmed Corporation.
[101860321]
The unused device was returned to conmed in original packaging. Visual inspection revealed a small hole on the product packaging poly adjacent the middle of the complaint device. This hole resulted in a breach of sterility of the product. Due to the appearance and location of the defect area, it not likely a manufacturing related issue. 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. Of the lot containing (b)(4) units, no prior complaints have been received. A two-year review of complaint history revealed 19 prior similar complaints. During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4). 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 issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[101860322]
The distributor in (b)(4) reported a "damage" on the sterile pouch of this 0035040 surgical tubing. There was no patient involvement as this defect was discovered during incoming inspection. This report is raised on the basis of a sterility breach found during the device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00063 |
| MDR Report Key | 7318221 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2016-07-11 |
| Date Added to Maude | 2018-03-06 |
| 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 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 | POOLE SUCTION INSTRUMENT 50/C |
| Generic Name | SURGICAL INSTRUMENTS, STERILE |
| Product Code | BYY |
| Date Received | 2018-03-06 |
| Returned To Mfg | 2017-07-14 |
| Catalog Number | 0035040 |
| Lot Number | 201607111 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-06 |