MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500; URINOMETER, MECHANICAL

Model Number 25104742

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

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.Additional patient/event information has been requested.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported that during routine observation of the patient, the patient and bed were found soaked and the urinary connector device on the urine meter was disconnected from the catheter.The catheter was reconnected and there were no further issues reported.The user also reported that it was unknown how long the catheter had been disconnected but there was no skin breakdown as a result of the urine spillage.

Manufacturer Narrative

Additional information was received from the critical care account executive to clarify complaint details: this user facility has reported problems in the past of the disconnection between the silicone catheters and connectors being a recurring issue which was dealt with by a colleague.I did not take responsibility for this product range until (b)(6) 2015.For clarification i am reporting this one instance, though i am aware of a previously submitted complaint for the same issue from this facility.A quality complaint investigation was performed on august 24, 2015.No sample was returned to assist with the investigation.No previous investigations are available.After a detailed batch review, no discrepancies related to the complaint issue were found.The issue is related to the foley catheter, which is not a part of product.No information about the catheter was provided.No changes related to 3k-connector were implemented.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: UNOMETER 500
• 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 (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4991650
• MDR Text Key: 22724378
• Report Number: 3007966929-2015-00068
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Not Applicable
• Report Date: 07/22/2015

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: No Information
• Device Expiration Date: 01/01/2020
• Device Model Number: 25104742
• Device Lot Number: 190839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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