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 2019-03-27 for URINE METER 25001183 manufactured by Unomedical Zavodskaya Street 50.
[140171814]
(b)(4). A batch record review was performed. No non-conformance report (ncr) related to complaint issue were initiated for complaint order during production. The batch record review resulted in discrepancy which was investigated via non-conformance within tw version 8. 3? Stop flow between patient and chamber of unometer product?. The investigation concludes the likely root cause for the issue? Stop flow between patient and chamber of unometer product? Cannot be identified on the base of information received. No corrective action (ca) is required at the moment. Video was reviewed and no new information was found. No samples and pictures were received. No additional investigation is needed. This issue will be monitored through the post market product monitoring review process. Based on the available information, this event is deemed to be a reportable malfunction. 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
[140171815]
The nurse reported a stop flow issue when using an unometer 500 device, on an icu post-op patient with low urine output. 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 further reported that it looks like there is some vacuum pressure that does not let the nrv to open. The nurse reported that to allow urine to flow, they opened the system by disconnecting the foley and then all the urine flowed down directly. 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 device was kept in place. Disconnecting the foley resolves the urine present in the tubing, but the issue returns each time the foley is re-connected. There was no reported patient harm. A video depicting the reported issue was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2019-00006 |
| MDR Report Key | 8456819 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-27 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-27 |
| 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 | 2019-03-27 |
| Model Number | 25001183 |
| Lot Number | 323355 |
| 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 | 2019-03-27 |