MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-02 for ARROW - HOWES 7 FR 3 LUMEN 30 CM UNKNOWN manufactured by Arrow International.
[19702655]
Triple lumen arrow catheter inserted right subclavian vein on may 1, 1994. Blue port accessed for iv fluids. On may 2, 1994 during injection of iv narcan at end of endoscopy procedure, it was noted that blue port separated from iv tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16781 |
| MDR Report Key | 16781 |
| Date Received | 1994-08-02 |
| Date of Report | 1994-05-20 |
| Date of Event | 1994-05-02 |
| Date Facility Aware | 1994-05-02 |
| Report Date | 1994-05-20 |
| Date Reported to Mfgr | 1994-05-20 |
| 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 | TRIPLE LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 1994-08-02 |
| Model Number | 7 FR 3 LUMEN 30 CM |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16714 |
| Manufacturer | ARROW INTERNATIONAL |
| Manufacturer Address | 300 BERNVILLE ROAD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-02 |