MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-11 for COOK INCORPORATED 8 CM DL 5182 395267 manufactured by Cook Critical Care Inc..
[1656]
Double lumen central line placed in l subdivision continued to leak profusely at insertion site. Attempt was made to thread new catheter over a guide wire @ original insertion. Following several attempts, a portion of wire was broken off and remained lodged in vessel. Placement verified by cxr; pt. Returned to or for successful removal of wiredevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, none or unknown, unanticipated, guidewire. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4355 |
| MDR Report Key | 4355 |
| Date Received | 1992-09-11 |
| Date of Report | 1992-05-04 |
| Date of Event | 1992-04-22 |
| Date Facility Aware | 1992-04-22 |
| Report Date | 1992-05-04 |
| Date Added to Maude | 1993-05-20 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK INCORPORATED |
| Generic Name | DOUBLE LUMEN CENTRAL VENOUS CATHETER TRAY |
| Product Code | GBP |
| Date Received | 1992-09-11 |
| Model Number | 8 CM DL 5182 |
| Catalog Number | 395267 |
| Lot Number | 653790 |
| ID Number | NI |
| Device Expiration Date | 1994-06-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4080 |
| Manufacturer | COOK CRITICAL CARE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-09-11 |