MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08,distributor,foreign, report with the FDA on 2015-06-04 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158101310190 manufactured by Unomedical Ltd..
[5840961]
It was reported an escape of urine is observed between the measuring chamber and the collection bag. It was further reported that the issue is the valve between measuring chamber and collection bag.
Patient Sequence No: 1, Text Type: D, B5
[13505818]
Based on the available information, this event is deemed 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
[56171215]
A quality complaint investigation was performed. A sample was not received from the customer. After a detailed batch review, a discrepancy (includes non-conformance/deviation) was not found. An event was initiated to define root cause. The investigation concludes the likely root cause for the issue "leakage between chamber and bag" cannot be identified on the basis of available information. No corrective action is required. The complaint will be closed. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. Reported to the fda on (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00053 |
| MDR Report Key | 4820842 |
| Report Source | 01,05,08,DISTRIBUTOR,FOREIGN, |
| Date Received | 2015-06-04 |
| Date of Report | 2015-05-21 |
| Date Mfgr Received | 2015-07-01 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-06-24 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIRECTOR |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 | 2015-06-04 |
| Model Number | 158101310190 |
| Lot Number | 174537 |
| Device Expiration Date | 2019-09-01 |
| 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 DIST MINSK REG, MINSKAYA BO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |