MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS, 110CM, 2L, RH; DEVICE, URINE FLOW RATE MEASURING

Model Number 158100410190

Device Problems Restricted Flow rate (1248); Infusion or Flow Problem (2964)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.This fda 3500a form represents an approximation of 168 devices and unknown number of patient that were reported for this complaint.There was no report of harm to the patient due to the device malfunction.Additional information has been requested, however no additional details have been provided, however should information be provided, a follow up report will be submitted.Note: this complaint issue occurred on (2) separate cases.A separate 3500a form has been completed for the other case.Reported to the fda on august 11, 2015.

Event Description

It was reported there was difficulty in draining urine through the antireflux valve to the chamber.The urine does not fall into the chamber, it gets stuck in the tubing.The nurse has to manually push the urine by pressing the tube towards the chamber.By doing this, the urine goes into the chamber.

Manufacturer Narrative

Corrected data for event investigation details: an investigation cannot be performed for the amount unknown; as it was communicated that the amount of devices affected is not known, lot numbers involved is not known and samples of the defective devices are not available or being returned.This information was not reported on mdr manufacturer report number 3007966929-2015-00071 submitted on august 11, 2015.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.(b)(4).

• Brand Name: UNOMETER SAFETI PLUS, 110CM, 2L, RH
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street ; 50 fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4999373
• MDR Text Key: 23662939
• Report Number: 3007966929-2015-00071
• 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: company representative,distri
• Reporter Occupation: Nurse
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100410190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2015
• 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