MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for THAL-QUICK CHEST TUBE TRAY G05463 C-TQTSY-2000 manufactured by Cook, Inc..
[81024204]
Patient Sequence No: 1, Text Type: N, H10
[81024205]
Physician unable to advance 22 fr dilator cooks chest tube kit onto guide wire. Lumen for dilator extremely small causing bending of the guide wire and not allowing dilator to advance to complete chest tube insertion. Dilator and guide wire with packaging sent to hospital materials management department for vendor notification. Manufacturer response for chest tube kit, cooks (per site reporter): no charge replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6743543 |
| MDR Report Key | 6743543 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-07-10 |
| 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 | 2017-07-26 |
| 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 | 2017-07-26 |
| Returned To Mfg | 2017-05-24 |
| Model Number | G05463 |
| Catalog Number | C-TQTSY-2000 |
| Lot Number | 6797405 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 6300 N. MATTHEWS DR. ELLETTSVILLE IN 47429 US 47429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-26 |