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

Model Number 158100150190

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that "the double lumen tubing on the unometer safeti plus was not draining into compartment- patients complaining of full bladder- nurses have to milk tubing for urine to start flowing.This occurs multiple times on a single shift.When product was removed, urine was flowing freely" when an alternate product was applied the urine was flowing into that unit.It was further reported that the complainant confirmed that the product (unometer safeti plus) was being used as per the information of use.Additional information was received informing that ¿the patients would feel they has a full bladder and needed to void and there was nothing in the urine meter, so this would have been when the urine meter was first being used.When the tubing was milked, this allowed urine to flow, but then would stop again multiple times during a shift.

• 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
• Manufacturer (Section G): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8672504
• MDR Text Key: 147171189
• Report Number: 3007966929-2019-00013
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 158100150190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1