MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS SYSTEM (WITH FIXED BAG; DEVICE, URINE FLOW RATE MEASURING

Model Number 158101310190

Device Problem Restricted Flow rate (1248)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.This fda 3500a represents an unknown number of devices and an unknown number of patients that were reported within this complaint.Additional patient/event details have been requested.However, no further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported the device developed an air lock, which caused the urine to stop draining and flow backward.This was especially true when the patient had low urine output.No patient complications were reported as a result of this event.

Manufacturer Narrative

Correction has been made to (device lot #), (device expiration date) and (device manufacture date) as this was submitted on the initial mdr incorrectly august 11, 2015 due to the device lot # being unknown.Additional information was received to clarify complaint details on august 05, 2015.It is unknown if all the alleged defective bags were from the same lot number as the one first reported.Approximately four unometers do not drain well and developed air locks.This information was discovered august 13, 2015.Additional information was received to clarify complaint details on august 13, 2015.The "number of affected products" was approximately four.It was confirmed that it is unknown the number of units that were actually used on patients and unknown the number of patients were involved.There were no units that were tested before using on the patients.It is unknown how many units were not opened at all.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 SYSTEM (WITH FIXED BAG
• 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 avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4999381
• MDR Text Key: 23417686
• Report Number: 3007966929-2015-00075
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 07/31/2015

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 Expiration Date: 09/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 174537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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