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

Model Number 158101210190

Device Problem Partial Blockage (1065)

Patient Problem Not Applicable (3189)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The complainant reports the valve within the connector (towards the indwelling catheter) was blocked; sterile water did not pass the valve from the indwelling catheter into the urinometer chamber.The complainant further states the device was tested prior to using on a pt.

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 event details have been requested.Should additional info become available a follow-up report will be submitted.Reported to the fda on 01/12/2015.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 00002 2275; BO 0000222750
• Manufacturer Contact: matthew walenciak, int asso dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4421969
• MDR Text Key: 5165230
• Report Number: 3007966929-2015-00017
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/18/2014

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: 02/01/2019
• Device Model Number: 158101210190
• Device Lot Number: 497671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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