MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI+,150CM,2L,RH; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 158101310190

Device Problem Leak/Splash (1354)

Patient Problem Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 11/2019.Manufacture date: 12/2015.Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.Reported to the fda on september 28, 2016.(b)(4).

Event Description

Complaint received reporting that "there is a leak between the chamber and the pouch at the top of the pouch." no further information was available.

Manufacturer Narrative

The device history records were reviewed and the batch was released according to requirements.The manufacturer did not find any nonconformity during the production lot.All relevant tests during production of the affected lot# 223486 were performed, registered and the results were in compliance with requirements.Machine logbooks were checked.Due to technical problems with the tearing station and the change of the grippers at the tearing system these were registered in the machine logbooks and the production staff was notified of the defect.A query was run against lot# 223486 which yielded 7 associated occurrences.A non-conformance (nc) was opened and investigated in an associated complaint.The nc has been closed and no additional action is required and this complaint will be closed.This issue will be monitored through the 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+,150CM,2L,RH
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5984198
• MDR Text Key: 55884836
• Report Number: 3007966929-2016-00085
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Device Lot Number: 223486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1