MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-04 for HICKMAN 0602210 manufactured by Dava/bard Access Systems.
[4956]
Subclavian vein thrombosis 2 degree port-a-cath. Port-a-cath removed. New port-a-cath implanted. Device 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, none or unknown, none or unknown, port. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6721 |
| MDR Report Key | 6721 |
| Date Received | 1993-10-04 |
| Date of Report | 1993-02-09 |
| Date of Event | 1993-02-02 |
| Report Date | 1993-02-09 |
| Date Added to Maude | 1993-10-13 |
| 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 | HICKMAN |
| Generic Name | PORT-A-CATH |
| Product Code | LKG |
| Date Received | 1993-10-04 |
| Model Number | 0602210 |
| Lot Number | 36JC0999 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6405 |
| Manufacturer | DAVA/BARD ACCESS SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-10-04 |