MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-10 for GESCO * 4000527 manufactured by Utah Medical Products.
[16054899]
White portion of stopcock came off while the rn was turning the stopcock. Break in system and pd fluid leaked out at the stopcock site. What was the original intended procedure? Dialysis. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3144747 |
| MDR Report Key | 3144747 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-04-29 |
| Report Date | 2013-05-09 |
| Date Reported to FDA | 2013-05-10 |
| Date Reported to Mfgr | 2013-06-04 |
| Date Added to Maude | 2013-06-04 |
| 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 |
| 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 | GESCO |
| Generic Name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Product Code | FKO |
| Date Received | 2013-05-10 |
| Returned To Mfg | 2013-04-25 |
| Model Number | * |
| Catalog Number | 4000527 |
| Lot Number | 1122637 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-10 |