MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-01-13 for UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER 158101210190 manufactured by Unomedical Ltd..
[5277668]
The complainant reports the valve within the connector (towards the indwelling catheter) was blocked; sterile water did not pass the valve from the indwelling catheter into the urinometer chamber. The complainant further states the device was tested prior to using on a pt.
Patient Sequence No: 1, Text Type: D, B5
[12716187]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. Additional event details have been requested. Should additional info become available a follow-up report will be submitted. Reported to the fda on 01/12/2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00019 |
| MDR Report Key | 4421946 |
| Report Source | 01,08 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-18 |
| Date of Event | 2014-12-17 |
| Date Mfgr Received | 2014-12-18 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-01-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT ASSO DIC |
| 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 | 2015-01-13 |
| Model Number | 158101210190 |
| Lot Number | 497671 |
| Device Expiration Date | 2019-02-01 |
| 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 DISTRICT MINSK REGION 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-13 |