MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS WITH LUER SAMPLE PORT; DEVICE, URINE LOW RATE MEASURING, 78FFG

Model Number 413455

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported a hospital complained that 50 devices presented issue.In some devices the urine came out on the chamber, some devices presented the break in the pouch's weld, some devices when they try to open the valve the urine doesn't drop to the chamber and in other devices, the handle is hard to move.It was stated, the complainant doesn't have details about the hospital's complaint.This report is to encompass the urine came out of the chamber issue.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There was no report of harm to the pt.It was stated, the device was removed or discontinued (it was discarded and a new one was placed.) additional info was received which stated, "we don't have anymore info about these cases.We just know that the 50 units (or more) presented issue, but we don't know how many units presented issue in the chamber, or in the handle, or in the pouch.The hospital doesn't have this info registered, but we orientated the hospital about the importance of registering complaints." the true root cause for the failure "the urine came out on the chamber" cannot be identified on the base of info received.Additionally, info was requested from supplier of bag.History records of manufacturing process have been checked for all mentioned batch.The results of review showed that all relevant tests performed during manufacturing process and final product release had been fulfilled and met the requirements.No nonconformity was registered during production process as well as packaging.All required tests have been performed according to requirements.No discrepancy has been detected during testing." complaint history 2013-(b)(6) 2014 was reviewed; the investigation of this issue was performed.No corrective action is required at the moment.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.A return sample for eval is not expected.Note: there are (b)(4) cases associated with this device; therefore, a separate fda form 3500a has been generated to address the other (b)(4) cases.

• Brand Name: UNOMETER SAFETI PLUS WITH LUER SAMPLE PORT
• Type of Device: DEVICE, URINE LOW RATE MEASURING, 78FFG
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 2275 0
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4058791
• MDR Text Key: 4903627
• Report Number: 3007966929-2014-00071
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: 413455
• Device Catalogue Number: 413455
• Device Lot Number: 652209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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