MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500, URINE METER; URINOMETER, MECHANICAL

Model Number 2539742

Device Problem Disconnection (1171)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

A unit clerk reported on behalf of staff nurses the device's tube disconnected from the patient's catheter during use.As a result urine has leaked onto the patient's bed.

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).

Manufacturer Narrative

A quality investigation was performed.Product samples were not available to assist with the investigation.The device history record (dhr) was reviewed and there were no related non-conformances concerning the complaint issue.Additional information was requested regarding the complaint issue, but no additional information was received to date.The issue is related to the foley catheter, which is not a part of the product.No information about the catheter was provided.The root cause cannot be identified based on the information received.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

Add'l information was received.A complaint query was generated using the following parameters: date range of october 28, 2014 to april 8, 2015; brand name type: unometer 500-urinemeter.The results of the query identified a total of 30 reported complaints for this reported complaint issue- connection issues.Six were identified as being associated with reference number (b)(4).No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

On december 21, 2015, it was discovered the brand name listed on the initial report was incorrect.The brand name has been updated.

• Brand Name: UNOMETER 500, URINE METER
• 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 (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365244681
• MDR Report Key: 4339760
• MDR Text Key: 5205500
• Report Number: 3007966929-2014-00122
• 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: 2539742
• Device Lot Number: 158092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• 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