MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500 - URINEMETERS; URINE FLOW RATE MEASURING NON-ELECTR

Model Number 158101310190

Device Problem Disconnection (1171)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

It was reported during the past couple of months the intensive care unit staff came across devices where the tubing detached from the chamber after trying to empty the urine into the chamber.

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.Numerous attempts were made to obtain additional patient/event information but, no information has been provided to date.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

A final quality evaluation was performed.A product complaint sample was received to assist with the evaluation.Visual inspection was performed.It was found that the tube was detached.Remains of glue were observed.The double lumen was measured.The outer diameter is in accordance with specification, but the cylinder was in wrong position.The possibility of customer misuse is increased by the fact that the cylinder in complaint sample was overturned.The device history record (dhr) was reviewed and there were no related non-conformances concerning the complaint issue.Complaints were analyzed and no negative trend was identified.A corrective preventive action was initiated on the basis of root cause investigation.The complaint lot number was produced prior to implementation of capa.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information received regarding investigation: a query was generated to capture all complaints with a similar reported complaint issue: loss of physical integrity within the date range of october 28, 2014 to april 21, 2015 and brand name type: unometer 500 - urinemeters.The results of the query identified a total of 12 reported complaints for this issue.One was identified as being associated with the icc code (b)(4).There were a total of 7 complaints for the malfunction code: inlet tubing detaches from the connector or drainage bag/urine measurement chamber, leakage may occur, of these only 1 was identified as being associated with the same icc code.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: UNOMETER 500 - URINEMETERS
• Type of Device: URINE FLOW RATE MEASURING NON-ELECTR
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4339664
• MDR Text Key: 20361483
• Report Number: 3007966929-2014-00115
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• 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: 11/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Device Lot Number: 154921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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