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 2015-02-11 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158101310190 manufactured by Unomedical Ltd..
[19499510]
The intensive care unit (icu) nurse reports the burette separated from the main collection chamber of the unometer safeti plus while the patient was being escorted from the bathroom and 'urine spilled over the floor and splashed onto the icu nurse who was escorting the patient. ' the icu nurse further reports the unometer safeti plus was in place for two days when the burette separated from the main collection chamber. It was also reported that the device was removed from the patient and was replaced.
Patient Sequence No: 1, Text Type: D, B5
[19623856]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00025 |
| MDR Report Key | 4511145 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-27 |
| Date Mfgr Received | 2015-01-29 |
| Date Added to Maude | 2015-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK |
| 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 & LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-02-11 |
| 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, MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-11 |