MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-29 for UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER 158101310190 manufactured by Unomedical Ltd..
[21065651]
The nurse reports the unometer safeti plus was in place approximately thirty minutes when the intensive care unit patient received intravenous diuretics because urine was not being produced. The nurse further reports the problem was found to be a defective open/close lever on the urine measurement chamber which caused urine to flow through the measurement chamber directly into the collection bag. It is also reported the defective device was removed and a new device was placed. The nurse also reports the patient did not experience injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[21504641]
Based on the available information, this event is deemed a reportable malfunction. No further information was available at the time of the report. There were no reports of the patient being harmed as a result of this malfunction. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[50137658]
Additional information was received 06/29/2015. The lot number and product evaluation sample are not available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00057 |
| MDR Report Key | 4877708 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-26 |
| Date Mfgr Received | 2015-06-17 |
| Date Added to Maude | 2015-06-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MATTHEW WALENCIAK,INTERIM ASSOC D |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-06-29 |
| Model Number | 158101310190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION, MINSKA 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |