MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-14 for DIALY-NATE 4000527 * manufactured by Utah Medical Products Inc..
[19021935]
Dialynate system from packaging pulled to extend both lines on coil to be on same side of coil. The piece connecting to the buretrol was torn from the coil system and product could not be used. No harm to patient. Defective product exchanged with the manufacturer for new product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921576 |
| MDR Report Key | 2921576 |
| Date Received | 2013-01-14 |
| Date of Report | 2013-01-14 |
| Date of Event | 2012-12-12 |
| Report Date | 2013-01-14 |
| Date Reported to FDA | 2013-01-14 |
| Date Added to Maude | 2013-01-18 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | DIALY-NATE |
| Generic Name | CATHETER, PERITONEAL DIALYSIS |
| Product Code | FKO |
| Date Received | 2013-01-14 |
| Model Number | 4000527 |
| Catalog Number | * |
| Lot Number | 1121990 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS INC. |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-14 |