MAUDE Adverse Event Report: CONVATEC, INC. ABVISER AUTOVALVE; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABVISER AUTOVALVE

Device Problem Defective Component (2292)

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

Event Date 04/05/2018

Event Type  malfunction  

Event Description

Bladder pressure monitoring device in use.40cc intravascular fluid (ivf) instilled and device controlled to release fluid after 2-3 minutes.Patient with no urinary output for several hours despite bladder pressure monitoring and instilled ivf into bladder.Removed device, 70cc urine drained from bladder.Device malfunctioned and was not releasing urine or fluid.No patient harm or change in care due to malfunction.No model number or serial number on device as container was thrown away upon initiation.Device not available for return.

• Brand Name: ABVISER AUTOVALVE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC.; 7900 triad center drive; suite 400; greensboro NC 27409
• MDR Report Key: 8068606
• MDR Text Key: 127125286
• Report Number: 8068606
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2018

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: Other
• Device Model Number: ABVISER AUTOVALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA