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

Model Number 25045051

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Postal code: (b)(6), phone number: (b)(6).Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported for this complaint.No lot number or product evaluation sample is available, a detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.

Event Description

Complaint received from a healthcare professional reporting a physical integrity issue with the device after a "few days" of patient use.Reporter stated "the middle of the collection chamber is broken during use, and thereby the collecting chamber can be disassembled and it is thereby leaking.Collection chamber breaking during use.When opened or closed, the chamber may break and come apart.The consequence is that the system is leaking and flowing urine all over the place." the reporter provided no patient details, but stated the device was changed to a new one.Photos provided by the reporter show the inlet tubing and open/close level have detached from the chamber.The reporter stated that the device is not available for return.

• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5526852
• MDR Text Key: 41214556
• Report Number: 3007966929-2016-00012
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25045051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• 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