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

Model Number 413454

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 12/2020.Manufacture date: 01/2016.Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.A batch record indicates that no non-conformances and deviations related to complaint issue were initiated.The batch record review resulted in a discrepancy which was previously investigated and is closed.The previous investigation defines the possible root causes for the issue but, a true root cause cannot be identified on the base of information received.This issue will be monitored through the post market product monitoring review process.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 07, 2016.(b)(4).Note: two cases associated with this complaint.A separate fda form 3500a has been completed for the unknown number of devices associated with this complaint.

Event Description

Complaint received reporting that "the luer lock valve is not hermetic and result in leaking of urine in the luer lock valve port." no further information was provided.

• Brand Name: UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK
• 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: 5933840
• MDR Text Key: 54151218
• Report Number: 3007966929-2016-00073
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413454
• Device Lot Number: 220378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• 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