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

Model Number 158101310190

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Not Applicable (3189)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The nurse reports unpacking the unometer safeti plus and saw an object that looked like hair 'trapped inside urine meter chamber.' the nurse further reports the device was not used on a patient.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Should additional information become available, a follow-up report will be submitted.Reported to the fda on 02/20/2015.

• 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, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4546676
• MDR Text Key: 5508635
• Report Number: 3007966929-2015-00029
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/11/2015

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 Expiration Date: 04/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 161969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 02/23/2015
• Date Device Manufactured: 05/01/2014
• 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