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

Model Number 158101310190

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/23/2014

Event Type  malfunction  

Event Description

It was reported the urinometer was attached to the patient's catheter; when the patient was turned, approximately 2 hours later, the nurse noted the urinometer had become detached from the catheter.As a result, the patient's bed linens were wet.The urinometer was discontinued at that time and replaced with a leg bag.

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.No additional patient/event details were available at the time of this report.Should additional information becomes available, a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
• Type of Device: URINOMETER, MECHNANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district, minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, interim assoc. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4432354
• MDR Text Key: 5380511
• Report Number: 3007966929-2015-00022
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 170548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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