MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500 - URINEMETERS; DEVICE, URINE FLOW RATE MEASURING

Model Number 158101310190

Device Problem Leak/Splash (1354)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported urine was draining slowly from the measuring chamber into the collection bag regardless of the drain being opened or closed, thus the patient received treatment for minimal urine output when not required.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It was stated the device was used on a patient and the device was replaced.It was stated the patient was given fluid and frusemide, a diuretic, which was stated to have no harmful effects on the patient.A follow-up email was received on (b)(6) 2014 which stated, the user did not require additional medical treatment or intervention.It was also stated, "that the complainer thinks the patient was 'cardio-thoracic' and will have had 'grafts', however, this was not confirmed." the complainer believes the device was attached to the patients' catheter in the 'theater', but the complainer is not sure whether the fault occurred immediately or was acquired through use.A lot number was requested; however, it was not able to be obtained.A final quality evaluation was performed on (b)(4) 2014.It was stated the device history record (dhr) cannot be reviewed, because the lot is unknown.The true root cause cannot be identified based on the received information.Convatec will continue to observe for trends regarding these complaint types.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: UNOMETER 500 - URINEMETERS
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 0000 ; BO 0000
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3856492
• MDR Text Key: 4661434
• Report Number: 3007966929-2014-00013
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Device Catalogue Number: 158101310190
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• 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