MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2017-07-30 for POOLE SUCTION INSTRUMENT 50/C 0035040 manufactured by Conmed Corporation.
[81372486]
The reported poole suction instrument was returned in its original unopened packaging to conmed for evaluation of "defective seal". Label verification was performed. Visual inspection by the packaging engineer confirmed a breach of sterility. Further inspection of the device determined the device was in the seal area during the sealing process in the form fill/seal machine. 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, one additional complaint has been filed for this failure. A review of complaint history revealed 15 complaints have been reported in the past two years. (b)(4). This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation. There was no patient involvement. Clinical practice would include examination and verification of the product and its original packaging to ensure both are intact. This package was not sealed and therefore would prompt the end user to discard it and obtain a new sterile device. To date there have been no reported long term adverse effects related to this issue, however, an investigation has been initiated to prevent further occurrences.
Patient Sequence No: 1, Text Type: N, H10
[81372487]
The distributor in (b)(4) reported a defective seal on item 0035040- poole suction instrument. In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user. This report is raised on the basis of a malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2017-00176 |
| MDR Report Key | 6753176 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2017-07-30 |
| Date of Report | 2017-07-30 |
| Date Mfgr Received | 2017-06-19 |
| Device Manufacturer Date | 2016-10-03 |
| Date Added to Maude | 2017-07-30 |
| 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 | POOLE SUCTION INSTRUMENT 50/C |
| Generic Name | SURGICAL INSTRUMENTS, STERILE |
| Product Code | BYY |
| Date Received | 2017-07-30 |
| Returned To Mfg | 2017-07-25 |
| Catalog Number | 0035040 |
| Lot Number | 201610031 |
| 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 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-30 |