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 |