MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-02-06 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 413454 manufactured by Unomedical Ltd..
[37616335]
(b)(6) 2019. (b)(6) 2014. Based on the available information, this event is deemed a reportable malfunction. The device was not used on a patient. Additional event information has been requested but not yet received, should additional information become available, a follow-up report will be submitted. A detailed batch review for this lot number was performed, it was concluded that there was no discrepancy related to this complaint issue. A previous investigation revealed an unidentifiable root cause and required no corrective actions. Therefore, this complaint will be closed without further action (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37616336]
Report from a pharmacist stating that "the catheter connector is broken where the unometer device is connected to the foley catheter" reporter stated that the product was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2016-00002 |
| MDR Report Key | 5414665 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-02-06 |
| Date of Report | 2016-01-13 |
| Date of Event | 2015-12-19 |
| Date Mfgr Received | 2016-01-13 |
| Date Added to Maude | 2016-02-06 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| 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 | 2016-02-06 |
| Model Number | 413454 |
| Lot Number | 169481 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 VOBLAST 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-06 |