MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-13 for OPEN TIP YANKAUER WITH VENT 0034980 manufactured by Conmed Corporation.
[183306017]
At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[183306018]
During incoming inspection, the distributor rejected this device, open tip yankauer with vent , catalog # 0034980, lot 201810011, for a possible insufficient heatseal. There was no contact with the patient as this was found during incoming inspection. Due to the potential severity of a breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00067 |
| MDR Report Key | 9706025 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2020-02-13 |
| 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 TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995557 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN TIP YANKAUER WITH VENT |
| Generic Name | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | GCX |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 0034980 |
| Lot Number | 201810011 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |