MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-25 for DIALY-NATE * 4000527 manufactured by Utah Medical Products, Inc..
[3235311]
When nurse removed dialynate system from packaging, she pulled to extend both lines on coil to be same side of coil. When this was done, the piece near the buretrol tore from the coil system and the product could not be used. The coiled part eventually broke off. This facility is seeing a trend with this product. Product was not actually used on the patient. No patient harm occurred. The local product rep is working with a hospital rep to replace all of the current products with this lot number. Staff are continuing to use the product lot numbers until replacements are found. Staff have been educated on inspecting carefully prior to using for any breaks or holes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2933130 |
| MDR Report Key | 2933130 |
| Date Received | 2013-01-25 |
| Date of Report | 2013-01-25 |
| Date of Event | 2012-12-12 |
| Report Date | 2013-01-25 |
| Date Reported to FDA | 2013-01-25 |
| Date Added to Maude | 2013-01-29 |
| 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 | 2013-01-25 |
| Model Number | * |
| Catalog Number | 4000527 |
| Lot Number | 1121990 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| 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 | 2013-01-25 |