MAUDE Adverse Event Report: UNOMEDICAL, LTD. UNOMETER SAFETI PLUS SYSTEM; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 158100140190

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 11/11/2015

Event Type  malfunction  

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 further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Patient height: 180 cm.A complaint sample was not returned for evaluation.A detailed batch review was performed and no non-conformances related to this event were found.A previous investigation was opened based on similar complaints.The investigation concluded that the root cause for the reported issue could not be identified.No corrective actions are required at the moment.Trends of such complaint issues will continue to be monitored.Reported to the fda on december 21, 2015.(b)(4).

Event Description

It was reported after 3 hours of use, the nursing staff noted the unometer appeared to be nonfunctional as "urine was not flowing to the [device]." upon closer inspection, the nursing staff found the walls of the measuring chamber had cracked.The patient's urine had flowed into the device properly and then onto the floor.The device was removed and replaced.No patient complications were reported as a result of this event.

• Brand Name: UNOMETER SAFETI PLUS SYSTEM
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL, LTD.; zavodskaya str. 50; fanipol 222750; dzerzhinsk district,, minsk ; BO
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365244681
• MDR Report Key: 5315406
• MDR Text Key: 34021011
• Report Number: 3007966929-2015-00105
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 158100140190
• Device Lot Number: 169481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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
• Patient Age: 77 YR
• Patient Weight: 76