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

Model Number 158101310190

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

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

Event Date 06/26/2015

Event Type  malfunction  

Event Description

The nurse reports the unometer safeti plus was in place approximately thirty minutes when the intensive care unit patient received intravenous diuretics because urine was not being produced.The nurse further reports the problem was found to be a defective open/close lever on the urine measurement chamber which caused urine to flow through the measurement chamber directly into the collection bag.It is also reported the defective device was removed and a new device was placed.The nurse also reports the patient did not experience injury or harm.

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.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received 06/29/2015.The lot number and product evaluation sample are not available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol; dzerzhinsk district minsk region, minska 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4877708
• MDR Text Key: 21065651
• Report Number: 3007966929-2015-00057
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• 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