MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER

Model Number 158101210190

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 01/26/2015

Event Type  malfunction  

Event Description

It was reported that during sampling from the urinometer the 'urine flowed too fast in several directions and with the slightest movement there was an important retrograde flow, even if the clamp is closed'.No patient consequences were reported as a result of this event.

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.Should additional information become available, a follow-up report will be submitted.This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.

Manufacturer Narrative

Additional information was received regarding the complaint details on june 04, 2015; the date may 08, 2015 is the date in which the follow up form was completed.The awareness date of the complaint is april 08, 2015.The complaint was reported within 24 hours after received.The complaint was received on april 08, 2015 and submitted to world wide product surveillance on april 09, 2015.This is part of record from 6/2015 from (b)(6) related to the unometer safeti plus system.How long the product was used by or on the patient is unknown and is not retrievable.Information of the patient was not provided and is not retrievable.Additional information was received on june 09, 2015 regarding the explanation of aware dates; "the initial report date was april 08, 2015 because the institution did not report the issues to convatec's officer until that date.Initially the institution informed all issues in one report, which were submitted to world wide product surveillance on april 09, 2015 (one day after the aware date).Further in the follow-up answer of may 08, 2015 they informed us that the report they had sent did not correspond to 1 event but to 5 events, which occurred 2 on (b)(6), 1 on (b)(6), 1 on (b)(6) and 1 on (b)(6)." "therefore we were aware of the issues with the device on april 08, 2015 but it was only until may 08, 2015 when we were informed that there were separate events and also of the dates of the events.Therefore you didn't receive this information before because the institution did not provide it to us before either." additional information was received on june 11, 2015 indicating that the lot # 655189 is associated to icc code/product (b)(4).No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

A quality complaint investigation was performed.After detailed batch review, no discrepancies (includes non- conformances/deviations) were found.A non-conformance for a previous event was opened.The investigation concludes the root cause for the issue cannot be identified on the basis of available information.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, interim assoc. ; 9083779293
• MDR Report Key: 4810773
• MDR Text Key: 5930750
• Report Number: 3007966929-2015-00048
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 158101210190
• Device Lot Number: 655189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2015
• 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