MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-29 for ARROW-HOWES AK-15703 manufactured by Arrow.
[15036001]
Triple lumen catheter inserted into left inguinal area. 5 hours later it was determined that guide wire had not been removed and that tip of wire was in right jugular. Necessitated surgical removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16792 |
| MDR Report Key | 16792 |
| Date Received | 1994-08-29 |
| Date of Event | 1994-01-08 |
| Date Facility Aware | 1994-01-09 |
| Date Added to Maude | 1994-10-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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-HOWES |
| Generic Name | MULTI LUMEN CENTRAL VENOUS CATHETER |
| Product Code | GBP |
| Date Received | 1994-08-29 |
| Model Number | AK-15703 |
| Lot Number | AK 1-275-3 |
| Device Expiration Date | 1996-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16725 |
| Manufacturer | ARROW |
| Manufacturer Address | 3000 BERNVILLE ROAD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-29 |