MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-10-20 for NIPRO A209/V803 manufactured by Nipro Medical Corporation.
[17833359]
Blood lines connected to pt. Treatment started. Venous luer lock connector on blood line began to leak unnoticed for 20 minutes. Pt lost approximately 50-100cc of blood. Luer lock connector was re-tightened and treatment was resumed without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2004-00004 |
| MDR Report Key | 550479 |
| Report Source | 05,06 |
| Date Received | 2004-10-20 |
| Date of Report | 2004-10-19 |
| Date of Event | 2004-09-10 |
| Date Mfgr Received | 2004-09-23 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2004-10-25 |
| 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 | 3 |
| Manufacturer Contact | CARY GOLDSMITH |
| Manufacturer Street | 3150 NW 107 AVE. |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 3055997174 |
| Manufacturer G1 | NIPRO (THAILAND) CORP |
| Manufacturer Street | 10/2 MOO 8, BANGNOMKO, SENA |
| Manufacturer City | AYUTHAYA 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPRO |
| Generic Name | DIALYSIS BLOOD LINES |
| Product Code | FIB |
| Date Received | 2004-10-20 |
| Model Number | A209/V803 |
| Catalog Number | A209/V803 |
| Lot Number | 04D03 |
| ID Number | NA |
| Device Expiration Date | 2009-06-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 540007 |
| Manufacturer | NIPRO MEDICAL CORPORATION |
| Manufacturer Address | * * * |
| Baseline Brand Name | NIPRO SET |
| Baseline Generic Name | BLOOD TUBING SET |
| Baseline Model No | A209/V803 |
| Baseline Catalog No | A209/V803 |
| Baseline Device Family | BLOOD SET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K010264 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-20 |