MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for 3 LUMEN 20 CM 0.035 PRODUCT AK 25703 manufactured by Arrow International, Inc..
[19140038]
Triple lumen catheter was inserted. When guidewire was removed the distal portion of wire came out unraveled or uncoiled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17772 |
| MDR Report Key | 17772 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-07-23 |
| Date of Event | 1994-06-15 |
| Date Facility Aware | 1994-06-15 |
| Report Date | 1994-06-23 |
| Date Reported to Mfgr | 1994-06-23 |
| Date Added to Maude | 1994-11-16 |
| 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 | 3 LUMEN 20 CM 0.035 |
| Generic Name | ARROW MLC 7.0 |
| Product Code | GBP |
| Date Received | 1994-07-29 |
| Catalog Number | PRODUCT AK 25703 |
| Lot Number | AK 2-087-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17689 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | 3000 BERNVILLE ROAD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-29 |