MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-05-15 for POOLE SUCTION WITH REMOVABLE SHEATH 0035040 manufactured by Conmed Corporation.
[75216025]
One (1) 0035040 poole suction instrument with removable sheath was returned to conmed for evaluation of "the seal of the sterile pouch was breached. " during visual inspection it was concluded that the device was in the seal area during the sealing process of the form, fill and seal machine. This open seal resulted in a breach of sterility therefore this complaint is confirmed. This device was manufactured on 10/17/2016. A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture. Of the lot containing (b)(4) units only this (b)(4) complaint has been received for "breach of sterile pouch. " a 2-year review of product family history has revealed (b)(4) complaints involving (b)(4) devices, of which (b)(4) were confirmed for this reported problem. During this same 2-year time frame over (b)(4) devices were sold worldwide making the occurrence rate for this failure mode (b)(4) percent. The reported packaging anomaly was obvious to the distributor, prompting return of the device for evaluation and replacement. This failure mode has been addressed in the risk documents. To date, there have been no long term adverse effects from any of these reported incidents however, an investigation has been initiated to prevent further occurrences. As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use). In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact. If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
Patient Sequence No: 1, Text Type: N, H10
[75216026]
As reported by the distributor in (b)(6), one (1) poole suction instrument with removable sheath was discovered to have an "insufficient heatseal or blister pack. " there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user. This report is being filed based on the potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2017-00112 |
| MDR Report Key | 6566605 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-10-17 |
| Date Added to Maude | 2017-05-15 |
| 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 | MRS. KIMBER BOSS |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243441 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POOLE SUCTION WITH REMOVABLE SHEATH |
| Generic Name | TUBE, ASPIRATING, FLEXIBLE, CONNECTING |
| Product Code | BYY |
| Date Received | 2017-05-15 |
| Returned To Mfg | 2017-05-08 |
| Catalog Number | 0035040 |
| Lot Number | 201610171 |
| 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 | 2017-05-15 |