MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER; URINOMETER, MECHANICAM

Model Number 15810130190

Device Problem Disconnection (1171)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

A health care professional reported the device was disconnected from the catheter.The disconnection caused urine to leak on the bed.The period of time the device was used when this incident occurred is unk.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.It was also reported, "the lot number (156456) is the one the complainant gave me when first discussed the issues on the unit.She thinks the catheters came from this is the lot number.No bags or packaging were kept and so cannot definitely confirm this," thus the lot number reported is not being utilized to capture this event.Note: issue occurred on (12) separate cases.A separate 3500a form has been completed for the other (11) cases.Should add'l info become available, a follow up report will be submitted.(b)(4).

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
• Type of Device: URINOMETER, MECHANICAM
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9073779293
• MDR Report Key: 4425993
• MDR Text Key: 20724874
• Report Number: 3007966929-2015-00007
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15810130190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• 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