MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS WITH LUER SAMPLE PORT; DEVICE, URINE FLOW RATE MEASURING

Model Number 413455

Device Problem Improper Device Output (2953)

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

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported by a distributor that the unometers did not work correctly.Three unometers when attempting to open the valve the urine did not drop the chamber.The unometers on the intensive care unit patients were discarded and replaced with another device.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.The device was used on a pt, however, there was no report of harm to the pt.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.A return sample for evaluation is not expected.Note: issue occurred on (3) separate cases.A separate 3500a form has been completed for the other (2) cases.

• Brand Name: UNOMETER SAFETI PLUS WITH LUER SAMPLE PORT
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district, minsk region; minskaya voblast 0000 2227; BO 000022275
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave; greensboro, NC 27409-0000 ; 9083779293
• MDR Report Key: 3966508
• MDR Text Key: 4624156
• Report Number: 3007966929-2014-00040
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: 413455
• Device Catalogue Number: 413455
• Device Lot Number: 652209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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