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

Model Number ABV331

Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)

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

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 additional information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported after eight (8) hours in use, the nurse noted that urine was not flowing in the catheter for two(2) hours.A bladder scan was performed and a total of 450cc's of urine was retained in the bladder.As a result, the device was removed and it was discovered that the autovalve did not deflate.The nurse further reported that the catheter drained 450cc's of urine output without issue after removal of the device.A new device was not placed as it was no longer clinically indicated and there was no adverse impact to the patient as a result of the defective device.

• Brand Name: ABVISER® AUTOVALVE® IAP MONITORING DEVICE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5307981
• MDR Text Key: 33830547
• Report Number: 1049092-2015-00721
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2015

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: Health Professional
• Device Model Number: ABV331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/17/2015
• 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: Initial
• Patient Sequence Number: 1