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

Model Number 158101310190

Device Problem No Flow (2991)

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

Event Date 02/17/2015

Event Type  malfunction  

Event Description

Complainant reported the device was in the patient for three weeks and on (b)(6) 2015 it was noted the open/close lever 'was stiff and difficult to turn and when it was turned open, urine did not flow down' to the collection bag.The complainant further reported the nurse had to replace the device because, the chamber was 'getting full'.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS WITH LUER-LOCK $ LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50 fanipol; dzerzhinsk district minsk region, minska 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4563168
• MDR Text Key: 20979336
• Report Number: 3007966929-2015-00031
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K996732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/02/2015
• 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: Initial
• Patient Sequence Number: 1