MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for WAYNE PNEUMOTHORAX SET FOR SELDINGER PLACEMENT manufactured by Cook Incorporated.
[177376218]
The guide-wire tip has about one centimeter that is partly broken off from the rest of the guide wire. This was caught before insertion and a new one was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659320 |
| MDR Report Key | 9659320 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-10 |
| Report Date | 2019-12-11 |
| Date Reported to FDA | 2019-12-11 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WAYNE PNEUMOTHORAX SET FOR SELDINGER PLACEMENT |
| Generic Name | CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-02-03 |
| Lot Number | 10005738 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |