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.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.Reported to the fda on august 11, 2015.

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

Additional information was received to clarify complaint details.The "number of affected products" was approximately four.It is unknown how many units were actually used on patients and how many 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).

Manufacturer Narrative

Additional information was received: a quality investigation was performed and after a detailed batch review, no discrepancies were found.A previous investigation on "stop flow between patient and chamber" was conducted and is being leveraged for this complaint.This previous investigation has been closed; therefore, this complaint will be closed without further action.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 fanipold zerzhinsk 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: 4999383
• MDR Text Key: 23663035
• Report Number: 3007966929-2015-00074
• 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: 09/15/2015
• 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