MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-06 for MULTILUMEN CATHETERT WITH BLUE FLEXTIP AK-14703 manufactured by Arrow International Inc..
[1674]
Triple lumen catheter removed on november 12, 1992 over guidewire and exchanged for swan ganz catheter. Chest x-ray on november 16, 1992 revealed "another piece of tubing overlying superior aspect of rt. Svc and rt. Atrium". This approximately 8 inch piece of catheter tubing was removed under fleuro in the cath lab. Device 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 not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: storage/shipment, incorrect technique/procedure, misapplication of device. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4100 |
| MDR Report Key | 4100 |
| Date Received | 1993-01-06 |
| Date of Report | 1992-12-02 |
| Date of Event | 1992-11-12 |
| Date Facility Aware | 1992-11-18 |
| Report Date | 1992-12-02 |
| Date Reported to Mfgr | 1992-11-20 |
| Date Added to Maude | 1993-05-13 |
| 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 | MULTILUMEN CATHETERT WITH BLUE FLEXTIP |
| Generic Name | MULTI LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 1993-01-06 |
| Catalog Number | AK-14703 |
| ID Number | 7 FR-3 LUMEN-30 CM |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3833 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-06 |