MAUDE Adverse Event Report: UNOMEDICAL LTD UNOMETER SAFETI PLUS - WITH LUER-LOCK; DEVICE, URINE FLOW RATE MEASURING

Model Number 158100140190

Device Problems Disconnection (1171); Leak/Splash (1354); Use of Device Problem (1670)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Device expiration date- 05/2020; manufacture date- 06/2015.Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported for this complaint.After a detailed batch review, no discrepancy, non-conformance or deviation related to this complaint issue was found.A previous open investigation is applicable to this complaint investigation, with a capa in progress.The complaint will remain open until completion of the previous investigation.The product information for use states the recommended usage time for the device is 7 days.This complaint states the device was used for 22 days.Should additional information become available, a follow-up report will be submitted.Reported to the fda on: march 23, 2016.(b)(4).

Event Description

Complaint received from a healthcare professional reporting a connection issue with the device.Reporter stated that 22 days ago a patient in the adult icu had an indwelling urinary catheter inserted and was connected to the device.Reporter stated that an assistant noticed that the "system started to leak urine at the connector of the tube with the measuring chamber." reporter stated that the issue was detected after a "revision of the device".Reporter stated the device was discontinued and the unit was not available to be returned.Photos provided by the reporter show the inlet tube disconnected between the anti-kink spiral and the open/close lever on the collection chamber.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD; zavodskaya street, 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5520424
• MDR Text Key: 41029919
• Report Number: 3007966929-2016-00011
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Other
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100140190
• Device Lot Number: 206060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• 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
• Patient Age: 77 YR
• Patient Weight: 77