MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-09-23 for THAL-QUICK CHEST TUBE TRAY C-TQTSY-1600 manufactured by Cook, Inc..
[16120712]
No prod was returned to assist with this investigation; therefore, we were not able to determine with certainty the root cause of the event. However, based on the info provided, it is possible the device may have met with resistance beyond its intended design. Our qc dept inspects this device for bends, kinks, adequate joint strength and other surface imperfections and verifies the curve configuration 100% prior to further processing. Nevertheless, the appropriate individuals were notified of this event and we will continue to monitor for similar reports.
Patient Sequence No: 1, Text Type: N, H10
[16255302]
Using sterile seldinger technique, a 16 fr chest tube was being inserted into the left chest of the pt. As the dilators were being used to enlarge the entry site over the wire, the wire was noted to be frayed and unwinding. The wire was removed from the pt, in total, and a new kit was used to complete the procedure successfully. Add'l info rec'd: the wire did fray and separate and was subsequently removed, intact, from the pt. No adverse outcome was noted for the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2008-00521 |
| MDR Report Key | 1179643 |
| Report Source | 05,06,07 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-08-25 |
| Date of Event | 2008-08-05 |
| Date Facility Aware | 2008-08-05 |
| Report Date | 2008-08-14 |
| Date Reported to Mfgr | 2008-08-14 |
| Date Mfgr Received | 2008-08-25 |
| Date Added to Maude | 2008-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THAL-QUICK CHEST TUBE TRAY |
| Generic Name | DQR CANNULA, CATHETER |
| Product Code | GBW |
| Date Received | 2008-09-23 |
| Model Number | NA |
| Catalog Number | C-TQTSY-1600 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1208585 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | * BLOOMINGTON IN 47404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-23 |