MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-11 for THAL-QUICK CHEST TUBE TRAY G05463 C-TQTSY-2000 manufactured by Cook, Inc..
[74908600]
Patient Sequence No: 1, Text Type: N, H10
[74908601]
During chest tube insertion, the physician was unable to advance the 22 fr dilator onto the guide wire. The lumen for the dilator was extremely small, causing bending of the guide wire which did not allow the dilator to advance. The physician had to trim the guide wire in order to hold position and a new kit with a 22 fr dilator was used to advance and allow completion of the chest tube insertion. Manufacturer response for chest tube insertion kit - 22 fr, (brand not provided) (per site reporter): none known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6559695 |
| MDR Report Key | 6559695 |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-05-04 |
| Report Date | 2017-05-08 |
| Date Reported to FDA | 2017-05-08 |
| Date Reported to Mfgr | 2017-05-08 |
| Date Added to Maude | 2017-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THAL-QUICK CHEST TUBE TRAY |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | PAD |
| Date Received | 2017-05-11 |
| Model Number | G05463 |
| Catalog Number | C-TQTSY-2000 |
| Lot Number | 6797405 |
| ID Number | 22 FR DILATOR |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-11 |