MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-19 for NOVY J-NCS-503500 G26822 manufactured by Cook, Inc..
[4928012]
During tubal cannulation procedure, it was noted that the distal end of the novy cannula broke off of the cannula device. This end of the device does not go into the patient. All pieces were recovered. Another device was procured and used as needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4143286 |
| MDR Report Key | 4143286 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-16 |
| Report Date | 2014-09-17 |
| Date Reported to FDA | 2014-09-19 |
| Date Reported to Mfgr | 2014-10-06 |
| Date Added to Maude | 2014-10-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVY |
| Generic Name | CATHETERS, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2014-09-19 |
| Model Number | J-NCS-503500 |
| Catalog Number | G26822 |
| Lot Number | U2207204 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIEL WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-19 |