MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-17 for ARROW LARGE BORE TWO-LUMEN CENTRAL VENOUS CATH KIT N/A AK-12122-H manufactured by Arrow International.
[1095]
Patient was admitted due to abdominal trauma. In operating room device was inserted in patient. Patient developed cardiac tamponade and died. After insertion an x-ray was taken to confirm placement. The insertion site was internal jugular vein. At autopsy, a puncture was found at root of aorta. This led to hemo-pericardium in cardiac tamponade and deathdevice labeled for single use. Patient medical status prior to event: unknown. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036499-1992-00003 |
| MDR Report Key | 2167 |
| Date Received | 1992-12-17 |
| Date of Report | 1992-11-23 |
| Date of Event | 1992-08-30 |
| Report Date | 1992-11-23 |
| Date Reported to FDA | 1992-11-23 |
| Date Reported to Mfgr | 1992-11-23 |
| Date Added to Maude | 1993-01-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW LARGE BORE TWO-LUMEN CENTRAL VENOUS CATH KIT |
| Generic Name | N/A |
| Product Code | GBP |
| Date Received | 1992-12-17 |
| Model Number | N/A |
| Catalog Number | AK-12122-H |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1993 |
| Manufacturer | ARROW INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-12-17 |