MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-30 for ARROW 00815357 * manufactured by Arrow Intl..
[122952]
1/3/98: during placement of port-a-cath at the cephalosubclavian route, the surgeon noticed a foreign body catheter in the superior vena cave. X-ray report confirmed the presence of the foreign body catheter. 4/7/98: removal of foreign body catheter. 1/7/98: x-ray demonstrated successful removal of foreign body catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 146706 |
| MDR Report Key | 146706 |
| Date Received | 1998-01-30 |
| Date of Report | 1998-01-19 |
| Date of Event | 1998-01-03 |
| Date Added to Maude | 1998-02-03 |
| 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 | 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 |
| Generic Name | SLIC-SINGLE LUMEN INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 1998-01-30 |
| Model Number | 00815357 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 142979 |
| Manufacturer | ARROW INTL. |
| Manufacturer Address | 2400 BERNVILLE RD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-30 |