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

Model Number 25039742

Device Problem Occlusion Within Device (1423)

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

Event Date 11/06/2014

Event Type  malfunction  

Event Description

A unit clerk reported on behalf of staff nurses the units are not allowing urine to drain through the top chamber.As a result urine has leaked onto patient's beds.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There are five (5) additional cases with similar problems manufactured under the same lot.Additional mdr (3500a) reports will be submitted for each case.There were no reports of the patient being harmed as a result of this malfunction.No additional patient/event details have been provided to date.Should additional info become available, a f/u report will be submitted.(b)(4).

• 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 voblasts 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak,dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4339782
• MDR Text Key: 5173995
• Report Number: 3007966929-2014-00116
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 25039742
• Device Lot Number: 158092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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