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

Model Number 158100510190

Device Problems Leak/Splash (1354); Unable to Obtain Readings (1516); Defective Component (2292)

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

Event Date 05/05/2015

Event Type  malfunction  

Event Description

The nurse reports the unometer safeti open/close lever is in the closed position (in order to measure urine output) however, after one hour it is observed the measurement chamber is empty; urine flows into the collection bag making it impossible to obtain the urine measurement.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at this time of the report.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.This complaint involves two devices, therefore a separate fda form 3500a will be drafted for each device.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50 fanipol; dzerzhinsk district minsk reg, minskaya 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4817924
• MDR Text Key: 16467340
• Report Number: 3007966929-2015-00051
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100510190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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