MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-05-22 for NIPRO SET BLOOD TUBING SET FOR HEMODIALYSIS A217/V806 manufactured by Nipro Medical Corporation.
[457797]
Approx 1 hour into dialysis treatment, blood was noticed leaking from the blood pump segment area. There was minimal blood loss and no harm was done to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056186-2006-00008 |
| MDR Report Key | 720831 |
| Report Source | 05,06 |
| Date Received | 2006-05-22 |
| Date of Report | 2006-05-15 |
| Date of Event | 2006-05-03 |
| Date Mfgr Received | 2006-05-04 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JESSICA OSWALD |
| Manufacturer Street | 3150 NW 107TH AVE. |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 9542410870 |
| Manufacturer G1 | NIPRO THAILAND |
| Manufacturer Street | * |
| Manufacturer City | AYUTHAYA 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPRO SET BLOOD TUBING SET FOR HEMODIALYSIS |
| Generic Name | BLOOD TUBING LINE |
| Product Code | FIB |
| Date Received | 2006-05-22 |
| Returned To Mfg | 2006-05-15 |
| Model Number | A217/V806 |
| Catalog Number | A217/V806 |
| Lot Number | 05L25 |
| ID Number | NA |
| Device Expiration Date | 2010-11-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 709902 |
| Manufacturer | NIPRO MEDICAL CORPORATION |
| Manufacturer Address | * MIAMI FL 33172 US |
| Baseline Brand Name | NIPRO BLOOD TUBING SET |
| Baseline Generic Name | BLOOD TUBING LINE |
| Baseline Model No | A217/V806 |
| Baseline Catalog No | A217/V806 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-22 |