MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for G43991 manufactured by Cook Medical Inc..
[59789930]
Patient Sequence No: 1, Text Type: N, H10
[59789931]
After the central line was placed, the white lumen was noted to be cracked where the hub meets the tubing resulting in need for an additional procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6099095 |
| MDR Report Key | 6099095 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-09-23 |
| Report Date | 2016-10-11 |
| Date Reported to FDA | 2016-10-11 |
| Date Reported to Mfgr | 2016-10-11 |
| Date Added to Maude | 2016-11-14 |
| 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 |
| 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 |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC |
| Product Code | GCE |
| Date Received | 2016-11-14 |
| Catalog Number | G43991 |
| Lot Number | 6919927 |
| ID Number | 4FR, 8CM DOUBLE LUMEN |
| Device Expiration Date | 2019-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |