MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-29 for URINE METER 25001183 manufactured by Unomedical Zavodskaya Street 50.
[141356185]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141356186]
It was reported that a stop flow issue occurred when using unometer 500 devices, specifically on intensive care unit (icu) patients with low urine output. It was further reported that this has been an ongoing issue that started approximately two months ago when they first started using unometer devices. It was reported that urine was being stopped in the entrance of the tubing into the chamber (right where there is the anti-kinking spiral) and in the foley catheter, right before getting into the kombikon connector. It was reported that it looks like there is some vacuum pressure that does not let the non-release valve (nvr) to open. The nurse reported that to allow urine to flow, they currently open the system by disconnecting the foley (and then all the urine flows down directly. The reporter indicated that in some cases? Even 40ml has fallen down to the chamber all of a sudden". It was also reported that another option they do sometimes is to? Milk? The tubing, but when using this method,? Some of the urine falls to the chamber but not as much as with opening the system". The devices are kept in place. Disconnecting the foley resolves the urine present in the tubing, but the issue returns each time the foley is re-connected. The reported could not provide the exact number of patients for which this issues had occurred, so this record was created to capture and report this information. There has been no reported patient harm. A video depicting the reported issue was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2019-00007 |
| MDR Report Key | 8465650 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-29 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-29 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Street | FE UNOMEDICAL LTD MINSK REGION |
| Manufacturer City | MINSKAYA VOBLASTS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2019-03-29 |
| Model Number | 25001183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Address | FE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |