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 2015-06-01 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100410190 manufactured by Unomedical Ltd..
[5930757]
It was reported the flow from the unometer safeti plus to the collector bag was "very slow (slower than usual) and at some moments the device needed to be manipulated'. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13416412]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested. Should additional information become available, a follow-up report will be submitted. This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00047 |
| MDR Report Key | 4810775 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-05-08 |
| Date Added to Maude | 2015-06-22 |
| 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, INTERIM ASSOC. |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 274090000 |
| Manufacturer Country | US |
| Manufacturer Postal | 274090000 |
| 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 |
| Product Code | EXR |
| Date Received | 2015-06-01 |
| Model Number | 158100410190 |
| Lot Number | 655189 |
| Device Expiration Date | 2018-06-01 |
| 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 00002227 BO 000022275 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |