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 2015-02-05 for UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER 158101310190 manufactured by Unomedical Ltd..
[5496957]
It was reported the unometer safeti plus was connected to the patient's foley catheter when the patient arrived in the intensive care unit. The nurse reportedly noticed the patient's abdomen was 'very large', the patient complained of pain and 'having consistent urinary urgency. ' further examination found, only thirty-five milliliters of urine had drained into the unometer safety plus. Initially, the nurse attempted to drain urine by repositioning the drainage tube. No additional urine resulted. An ultrasound was performed and the patient was noted to have 857 milliliters of urine in their bladder. The nurse manually irrigated the foley catheter and disconnected it from the unometer safety plus. This resulted in urine draining 'very fast. ' a 'fe' clots were noted at this time. When the foley catheter was reconnected to the unometer safeti plus, urine stopped draining. Again, the nurse disconnected the foley catheter from the unometer safeti plus and urine drained freely. The unometer safeti plus and foley catheter were reconnected and the unometer safeti plus was placed on the floor. Within ten minutes 800 milliliters of urine and waste had drained out from the patient. Finally, the nurse reports after two hours of use the initial unometer safeti plus was replaced with a new unometer safeti plus. Additional 245 milliliters of urine drained from the patient's bladder. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12913297]
Based on the available information, this event is deemed a reportable malfunction. There was no reports of the patient being harmed as a result of this malfunction. Additional patient and event details have been requested. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00023 |
| MDR Report Key | 4490289 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-05 |
| Date of Report | 2015-01-20 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2015-01-20 |
| Date Added to Maude | 2015-02-09 |
| 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 |
| 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 AND LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-02-05 |
| Model Number | 158101310190 |
| 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, MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-05 |