MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 UNOMETER; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 158101310190

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).

Event Description

It was reported "the timdiures kit requires the container to be held at ground level in order for the urine to drain into the container.A water lock is formed when the container hangs on the intensive care bed and the urine does not flow out of the bladder and into the container.Risk to patient safety regarding diuresis calculation and fluid balance calculation." no actual harm was reported.

Manufacturer Narrative

A batch record review was performed.No ncr related to complaint issue were initiated for complaint order during production.No samples or picture were received.Root cause investigation concerning ¿stop flow from the patient to chamber¿ was performed via event tw#: (b)(4) and is applicable for the complaint.Conclusion of the investigation is following: "on a base of the available information and investigation conducted the root cause for the issue ¿stop flow patient to chamber¿ cannot be identified.The list of possible causes was identified but no causes were confirmed.Based on analysis of data for the last three years no systematic failures in manufacturing process were revealed." no actions are required at the moment.No additional investigation is needed.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3007966929.

Event Description

To date no additional patient or event details have been received.

• Brand Name: UNOMETER
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer (Section G): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15658359
• MDR Text Key: 306991569
• Report Number: 3007966929-2022-00009
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Device Lot Number: 352570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1