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

Model Number 158101310190

Device Problem Positioning Failure (1158)

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

Event Date 12/04/2014

Event Type  malfunction  

Event Description

The nurse reported the blue open/close lever on the device was 'completely welded' and unable to be moved which prevented urine from draining into the collection chamber.The device had been in use for one hour when the fault was noted.It was further reported the staff replaced the device out with another unit.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.The date of the product expiration is unknown, only the month and year were provided.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 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4374321
• MDR Text Key: 5265419
• Report Number: 3007966929-2014-00135
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 158101310190
• Device Lot Number: 489237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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