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

Model Number 158100510190

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

It was reported that the pt had an urinometer placed while undergoing surgery.Initially, the pt had 'very low' diuresis.Two bottles of albumin 20% and five milligrams of furosemidum were administered to the pt with no result.The hosp staff then inspected the urinometer and found the insert to the chamber was loose and had stopped the flow of urine.No further info was provided.

Manufacturer Narrative

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.Additional pt and event details have been requested.Should additional info become available, a follow-up report will be submitted.(b)(4).

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
• Manufacturer (Section D): UNOMEDICAL LTD.; 50 fanipol; zavodskaya street; dzerzhinsk district minsk region, minska 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4563777
• MDR Text Key: 5472802
• Report Number: 3007966929-2015-00030
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 158100510190
• Device Lot Number: 491798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Required Intervention