MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-17 for DIALY-NATE 4000537 * manufactured by Utah Medical Products, Inc..
[3097783]
Dialysis drainage line disconnected from drainage bag. This set is a closed sysem for patient connection to peritoneal dislysis (pd) drainage bags and should not disconnect at this site. There was leakage at the stop cock that. During the use of this device this leak occurred twice. Patient required dosage of antibiotic post event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2880868 |
| MDR Report Key | 2880868 |
| Date Received | 2012-12-17 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-10-16 |
| Report Date | 2012-12-17 |
| Date Reported to FDA | 2012-12-17 |
| Date Added to Maude | 2012-12-20 |
| 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 | 0 |
| 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, SINGLE USE |
| Product Code | FKO |
| Date Received | 2012-12-17 |
| Model Number | 4000537 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 COTTONWOOD STREET MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-17 |