MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-04-26 for POOLE WITH REMOVABLE SHEATH 0035040 manufactured by Conmed Corporation.
[74145837]
Conmed corporation received two (2) "unopened" packages containing the poole with removable sheath for evaluation. The two packages were transferred to the packaging engineering lab for evaluation on 21-apr-2017. Visual examination of the returned packages found both packages open with product in the seal area of the complaint. Due to damage seen on the products, there is evidence that the devices were sealed within the sterile seal of the package. This complaint was confirmed regarding "the seal of the sterile pouch was breached. " this lot was manufactured on 03-oct-2017. 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), there are no similar complaints received. A two (2) year review of product history for this devices included in the capa investigation showed a total of (b)(4) complaints, involving (b)(4) devices, including this complaint, regarding insufficient heat seals. During this same two (2) year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this reported failure mode (b)(4) percent. The reported packaging anomaly was obvious to the distributor and therefore prompted the return of the device for evaluation and replacement. This failure mode is addressed in the risk documents. To date, there have been no serious injuries or death related to this reported problem. Nonetheless, to prevent future recurrences, an investigation is in progress to determine the root cause and to address this reported problem. 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
[74145838]
The distributor in (b)(6) reported that during receiving and inspection of incoming products, two (2) packages, containing one each poole with removable sheath, were discovered with "the seal of the sterile pouch was breached. " in this instance, there was no patient involvement with 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 | 1320894-2017-00102 |
| MDR Report Key | 6523353 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-04-26 |
| Date of Report | 2017-04-26 |
| Date Mfgr Received | 2017-04-21 |
| Device Manufacturer Date | 2016-10-03 |
| Date Added to Maude | 2017-04-26 |
| 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. RACHEL SCHOTT |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| 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 WITH REMOVABLE SHEATH |
| Generic Name | SUCTION INSTRUMENT |
| Product Code | BYY |
| Date Received | 2017-04-26 |
| Returned To Mfg | 2017-04-21 |
| 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 | 2017-04-26 |