MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-07-15 for NIPRO SET A209/V803 manufactured by Nipro (thailand) Corp. Ltd..
[418807]
Small amount of blood leak from connection of bloodline and femoral catheter. There was a small pooling of blood on patient leg under the catheter. Patient observed the leak prior to end of treatment. Treatment discontinued. Blood leak appeared to be at patient connection-venous bloodline to a temporary femoral catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2004-00002 |
| MDR Report Key | 613502 |
| Report Source | 05,06 |
| Date Received | 2004-07-15 |
| Date of Report | 2004-07-08 |
| Date of Event | 2004-06-04 |
| Date Mfgr Received | 2004-06-09 |
| Date Added to Maude | 2005-06-15 |
| 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 | 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. LTD. |
| 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 SET |
| Generic Name | BLOOD TUBING SET |
| Product Code | FIB |
| Date Received | 2004-07-15 |
| Model Number | A209/V803 |
| Catalog Number | A209/V803 |
| Lot Number | 03H20 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 603328 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA TH 13110 |
| 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 | 2004-07-15 |