MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-25 for 12 CM DL CVP 5 FR. manufactured by Cook Inc..
[16141006]
Pt. Abdomen noted to be swollen and chest tubes draining milky fluid. Abdomenal film confirmed right femoral line to be outside vessel, infusing tpn & fluids into abdomen. Line had been placed 6/29 0835. No device malfunction or user error identified. Pt. Tolerated placement of alternate linedevice labeled for single use. Patient medical status prior to event: fair 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7658 |
| MDR Report Key | 7658 |
| Date Received | 1994-01-25 |
| Date of Report | 1993-07-26 |
| Date of Event | 1993-07-01 |
| Date Facility Aware | 1993-07-01 |
| Report Date | 1993-07-26 |
| Date Reported to Mfgr | 1993-07-26 |
| Date Added to Maude | 1994-05-06 |
| 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 |
| Generic Name | DOUBLE LUMEN CATHETER |
| Product Code | FGH |
| Date Received | 1994-01-25 |
| Model Number | 12 CM DL CVP 5 FR. |
| Lot Number | 8963.190846 |
| ID Number | C VDL MY - 501J MIN - 051590 |
| Device Availability | N |
| Device Age | 01-MAY-93 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7337 |
| Manufacturer | COOK INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-25 |