MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for 0034350 manufactured by Conmed Corporation.
[95063244]
Patient Sequence No: 1, Text Type: N, H10
[95063245]
Upon setup for a case, a brown piece of debris was noted in a sterile suction tubing pack. Per site reporter: the manufacturer has initiated a quality review and will send an rma. They will also send replacement product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7124258 |
| MDR Report Key | 7124258 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-13 |
| Report Date | 2017-10-31 |
| Date Reported to FDA | 2017-10-31 |
| Date Reported to Mfgr | 2017-10-31 |
| Date Added to Maude | 2017-12-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | TUBE, ASPIRATING, FLEXIBLE, CONNECTING |
| Product Code | BYY |
| Date Received | 2017-12-18 |
| Model Number | 0034350 |
| Catalog Number | 0034350 |
| Lot Number | 201707285 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH RD. UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-18 |