MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-15 for CORE TRUMPET SUCTION /IRRIGATION CD8190 manufactured by Conmed Corporation.
[38807852]
Conmed corporation received one (1) unopened package containing the core trumpet suction/irrigation device for evaluation. Visual examination of the returned product noted there are small creases in the sealing area on the straight seal of the package (seal opposite chevron seal). It appears there are small channels within the creases that pass through the seal. This device was transferred to the packaging engineering test lab for dye leak testing. The packaging failed dye leak testing, on (b)(6) 2016, confirming there was a breach in the sterility of this device. This lot was manufactured on 26-jan-2015. A review of the device history record for this lot found no ncrs and no discrepancies noted during the manufacturing process. (b)(4). Preliminary investigation revealed the most probable cause of the creases found in the seal is manufacturing related. The manufacturing supervisors have been made aware of this reported problem and an investigation has been requested. To date, there have been no serious injuries or death related to this reported problem. To prevent future recurrences, an investigation has been opened to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[38807853]
The distributor in (b)(6) reported that during receiving and inspection of incoming products, "insufficient heat seal" was found in the sealing area of a sterile package containing the core trumpet suction /irrigation device. Testing results confirmed that the returned package exhibiting creases in the final manufacturing seal failed the dye leak test on (b)(6) 2016. There was no patient involvement with this reported device, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2016-00010 |
| MDR Report Key | 5436632 |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-04 |
| Date Mfgr Received | 2016-02-04 |
| Device Manufacturer Date | 2015-01-26 |
| Date Added to Maude | 2016-02-15 |
| 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 | MR. STEPHEN CASANOVA, RN, MPS |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, CHIHUAHUA CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORE TRUMPET SUCTION /IRRIGATION |
| Generic Name | CORE TRUMPET |
| Product Code | GBW |
| Date Received | 2016-02-15 |
| Returned To Mfg | 2015-10-15 |
| Catalog Number | CD8190 |
| Lot Number | 1501264 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-02-15 |