MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-20 for ARROW-HOWES 7FR 20CM AK-15703 manufactured by Arrow International, Inc..
[10054]
Triple lumen central venous catheter inserted via subclavian site on 9/28/93. On 10/1/93, per m. D. Order, the catheter was removed with only a 4. 5cm portion intact. 10/1/93, patient had remainder portion of catheter removed with a snare via a right femoral approach without difficulty or complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16517 |
| MDR Report Key | 16517 |
| Date Received | 1994-01-20 |
| Date of Report | 1993-10-14 |
| Date of Event | 1993-10-01 |
| Date Facility Aware | 1993-10-05 |
| Report Date | 1993-10-14 |
| Date Reported to Mfgr | 1993-10-14 |
| Date Added to Maude | 1994-09-30 |
| 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-HOWES |
| Generic Name | MULTI-LUMEN ARROW CATHETER |
| Product Code | GBP |
| Date Received | 1994-01-20 |
| Model Number | 7FR 20CM |
| Catalog Number | AK-15703 |
| Lot Number | AK-15703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16450 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | 300 VERNVILLE ROAD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-20 |