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

Model Number 158100140190

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 08/2020.Manufacturing date: 09/2015.Based on the available information, this event is deemed a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported that there was a urine leakage between the measuring chamber and the collector bag.It was noted that the product was used on a patient, but no patient information was provided.

Manufacturer Narrative

After detailed batch review, no discrepancies (includes non-conformances/deviations) related to complaint issue were found.A previous investigation is applicable to this complaint.This previous investigation has been closed.The investigation concludes that the likely root cause for the issue of leakage between the chamber and bag, could not be identified based on the information that was available.Therefore, this complaint will be closed without further action.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 & LUER-SLIP
• Type of Device: URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• 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: 5542468
• MDR Text Key: 41692751
• Report Number: 3007966929-2016-00014
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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: 212960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• 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