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

Model Number 25104742

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Mdr 3007966929-2020-00012 / device 1 of 1.(b)(6) hospital.Report source: (b)(6).Device manufacture date: 06/2019.Based on the available information, this event is deemed to be a reportable malfunction.Additional patient/event has been requested but, no additional information has been received to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by user facility that the device allowed "very little output".It is reported that the patient had a 10 french foley catheter (brand unknown) placed prior to commencement of surgery.When the patient was transported to pediatric intensive care unit (picu) post-surgery it was noted that there was "very little output noted in the unometer".The staff "flushed the catheter, but report despite flushing easily, the catheter did not drain anything".The patient was then re-catheterized and the unometer device was changed with an "immediate" outflow of 200ml into the unometer.Upon inspection by the user facility the note "white flap below tubing connection in unometer, not present in other same devices".It was further reported that it is ¿unclear if injury occurred,¿ but no harm was reported.No photograph depiction the reported complaint issue submitted by the complainant.

Event Description

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

Manufacturer Narrative

G.2: report source: medicines and healthcare products regulatory agency h.4: device manufacture date updated from 06/20 to 06/20/2019.A batch record review was performed.No non- conformance report (ncr) related to complaint issue were initiated for complaint order during production.No samples were received.Picture was received and evaluated.It is impossible to make any conclusions on the base of picture.Non-conformance ¿stop flow from patient to chamber¿ was initiated.Based on the available information and investigation conducted the root cause for the issue ¿stop flow at different areas from patient to chamber was observed by health care professional (hcp) during product use¿ cannot be determined.The list of possible causes was determined.Causes cannot be confirmed on the base of available information.No systematic failures in manufacturing process were revealed.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.No additional information has been received to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: URINE METER
• 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
• MDR Report Key: 9873372
• MDR Text Key: 186322260
• Report Number: 3007966929-2020-00012
• 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,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 25104742
• Device Lot Number: 327051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1