MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER; 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 Type  malfunction  

Manufacturer Narrative

Expiration date - 05/2020.Manufacturing date - 06/2015.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 august 08, 2016.

Event Description

It was reported "the urine leakage is detected as the unometer is connected to the foley catheter where the luer lock sampling port and the non-return valve are welded." it was further noted the failure was detected as the device was connected.The device was replaced.No further information was provided.

• Brand Name: UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER
• 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: 5854967
• MDR Text Key: 51453056
• Report Number: 3007966929-2016-00065
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 413454
• Device Lot Number: 206060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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: 67 YR