MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for 7 FR 20 CM TRIPLE LUMEN CATHETER AK-15703 manufactured by Arrow International.
[22185209]
Catheter broke off while trying to remove it, pt had catheter surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036499-1993-00024 |
| MDR Report Key | 15379 |
| Date Received | 1994-01-10 |
| Date of Report | 1993-11-12 |
| Date of Event | 1993-10-04 |
| Date Facility Aware | 1993-10-15 |
| Report Date | 1993-11-12 |
| Date Reported to FDA | 1993-11-12 |
| Date Added to Maude | 1994-08-22 |
| 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 |
| 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 | 7 FR 20 CM TRIPLE LUMEN CATHETER |
| Generic Name | CATHETER |
| Product Code | GBP |
| Date Received | 1994-01-10 |
| Catalog Number | AK-15703 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15373 |
| Manufacturer | ARROW INTERNATIONAL |
| Manufacturer Address | 3000 BERNVILLE ROAD READING PA 19065 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-10 |