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 2015-01-12 for UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER 15810130190 manufactured by Unomedical Ltd..
[5281008]
A health care professional reported the device was disconnected from the catheter. The disconnection caused urine to leak on the bed. The period of time the device was used when this incident occurred is unk.
Patient Sequence No: 1, Text Type: D, B5
[12869472]
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. It was also reported, "the lot number (156456) is the one the complainant gave me when first discussed the issues on the unit. She thinks the catheters came from this is the lot number. No bags or packaging were kept and so cannot definitely confirm this," thus the lot number reported is not being utilized to capture this event. Note: issue occurred on (12) separate cases. A separate 3500a form has been completed for the other (11) cases. Should add'l info become available, a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00005 |
| MDR Report Key | 4426015 |
| Report Source | 01,05,06 |
| Date Received | 2015-01-12 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2015-02-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INTERIM ASSOCA |
| 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 | 2015-01-12 |
| Model Number | 15810130190 |
| 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 | 2015-01-12 |