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

Model Number 158101310190

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  malfunction  

Manufacturer Narrative

Mdr 3007966929-2020-00004 / device 1 of 1.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the product distributor that "the urine is not flowing.The bag must be hung very low before the urine runs".According to the complainant the product was initially positioned "per the ifu" when the no flow was noted.The position of the device "was changed together with manipulating the tubing and then the urine flow was reestablished".There was no urine flow "into the tubing/chamber" of the device.Once the device was "placed on the floor the urine started flowing".The product was used on a patient and the patient experienced "some urine retention which was eventually seen on a bladder scan", no amount of retained urine reported.No photographs or videos submitted by the complainant depicting the reported complaint issue.

Manufacturer Narrative

This complaint has been evaluated.A batch record review was performed.No non-conformance report related to complaint issue were initiated for complaint order during production.A non-conformance for ¿stop flow from patient to chamber¿ was initiated.On a base of the available information and investigation conducted the root cause for the issue ¿stop flow at different areas from patient to chamber was observed by hcp (health care professional) during product use¿ cannot be determined.The list of possible causes was determined.No systematic failures in manufacturing process were revealed.No samples and pictures were received.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: reporting site: 1049092; manufacturing site: 3007966929.

Event Description

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

• 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: 9559603
• MDR Text Key: 175020569
• Report Number: 3007966929-2020-00004
• 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: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/01/2023
• Device Model Number: 158101310190
• Device Lot Number: 327320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1