MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS-W/LUER-LOCK & LUER-SLIP; URINOMETER, MECHANICAL

Model Number 158100410190

Device Problems Leak/Splash (1354); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The complainant reports when the open/close lever is in the closed position urine flows from the measurement chamber to the collection bag making it "impossible to obtain urine measurement.".

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.There were no reports of the patient being harmed as a result of this malfunction.Additional patient and event details have been requested.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

A quality complaint investigation was performed.Samples were not received.A detailed batch record review was performed.No non-conformance reports were initiated.A root cause investigation for the issue "urine is not collected in chamber" was performed.The true root cause cannot be identified based on the information received.No corrective action is required at the moment.A previous investigation is applicable to this complaint investigation.This previous investigation is closed.Therefore this complaint will be closed without further action.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 info providing the initial reporter of the complaint was received on june 16, 2015.This info was not captured on mdr 3007966929-2015-00046.F/u (1) submitted on july 2, 2015.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 06, 2015.

• Brand Name: UNOMETER SAFETI PLUS-W/LUER-LOCK & LUER-SLIP
• 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 Contact: matthew walenciak ; 9083779293
• MDR Report Key: 4804444
• MDR Text Key: 5897402
• Report Number: 3007966929-2015-00046
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: 158100410190
• Device Lot Number: 180454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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