MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-25 for NIPRO BLOODLINE A209/V803 A209V*03 manufactured by Nipro Medical Corporation.
[17073409]
Reporters reported that some of the nipro blood lines that they had received had a kink in the tubing. Initially, the problem was thought to be cosmetic in nature with no effect on performance. Further complaints were made that the kink "inhibits proper flow and causes complications during dialysis. " the venous line of an unused set is being held for pickup, and return to nipro medical corporation for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2316883-2006-00002 |
| MDR Report Key | 919469 |
| Date Received | 2006-10-25 |
| Date of Report | 2006-10-23 |
| Date of Event | 2006-10-19 |
| Date Facility Aware | 2006-10-19 |
| Report Date | 2006-10-23 |
| Date Reported to FDA | 2006-10-23 |
| Date Reported to Mfgr | 2006-10-23 |
| Date Added to Maude | 2007-09-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NIPRO BLOODLINE |
| Generic Name | BLOOD TUBING SET FOR DIALYSIS |
| Product Code | FIB |
| Date Received | 2006-10-25 |
| Model Number | A209/V803 |
| Catalog Number | A209V*03 |
| Lot Number | 06D05 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 892353 |
| Manufacturer | NIPRO MEDICAL CORPORATION |
| Manufacturer Address | * MIAMI FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-25 |