MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for THAL-QUICK CHEST TUBE SET G06787 manufactured by Cook, Inc..
[58072140]
Patient Sequence No: 1, Text Type: N, H10
[58072141]
Neonatal nurse practitioner was inserting chest tube when guide wire became faulty and started to unravel in the middle of the wire. Manufacturer response for thal-quick chest tube set 10 fr. 20 cm, thal quick chest tube (per site reporter): customer relations took all the necessary information and will send shipping label to ship back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6046240 |
| MDR Report Key | 6046240 |
| Date Received | 2016-10-21 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-10-10 |
| Report Date | 2016-10-13 |
| Date Reported to FDA | 2016-10-13 |
| Date Reported to Mfgr | 2016-10-13 |
| Date Added to Maude | 2016-10-21 |
| 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 SET |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | PAD |
| Date Received | 2016-10-21 |
| Returned To Mfg | 2016-10-14 |
| Catalog Number | G06787 |
| Lot Number | 7099646 |
| Device Expiration Date | 2019-07-06 |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-21 |