MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-21 for TROCAR NEEDLE DTN-18-20.0/G01377 manufactured by Cook Medical.
[20781121]
During percutaneous drainage of adnexal complex collections the "stylet" for the trocar needle would not pull out. Both pieces were removed and another trocar needle was utilized. Again the needle would not pull out. A third attempt was made with a trocar needle with a different lot number and no difficulty was noted. All with this lot number were pulled from the shelves and returned to the company for replacements.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036265 |
| MDR Report Key | 3835688 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-03-21 |
| Date Added to Maude | 2014-05-29 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROCAR NEEDLE |
| Generic Name | TROCAR NEEDLE |
| Product Code | FHP |
| Date Received | 2014-05-21 |
| Model Number | DTN-18-20.0/G01377 |
| Lot Number | 4604646 |
| Device Expiration Date | 2018-10-31 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-21 |