MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL

Model Number 413454

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(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).

Event Description

It was reported from a pharmacist that the measuring chamber was broken on the unometer, the product was unused.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5414652
• MDR Text Key: 37616273
• Report Number: 3007966929-2016-00001
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413454
• Device Lot Number: 170544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1