MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for AK-15703 manufactured by Arrow International.
[2850]
Immediately following right subclavian catheterization, patient experienced breathing difficulties. Following resuscitation efforts, patient expired. Final anotomical diagnosis on autopsy includes hemopericardiumdevice 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: visual examination. 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: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5141 |
| MDR Report Key | 5141 |
| Date Received | 1993-04-27 |
| Date of Report | 1993-02-18 |
| Date of Event | 1993-01-18 |
| Date Facility Aware | 1993-01-18 |
| Report Date | 1993-02-18 |
| Date Added to Maude | 1993-06-29 |
| 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 | MULTI-LUMEN CATHETER FROM SUBCLAVIAN CATHETER TRAY |
| Product Code | GBP |
| Date Received | 1993-04-27 |
| Model Number | AK-15703 |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 4843 |
| Manufacturer | ARROW INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-04-27 |