MAUDE Adverse Event Report: CONVATEC, INC ABVISER AUTOVALVE IAP MONITORING DEVICE

Model Number ABV301

Device Problems Inflation Problem (1310); Difficult to Open or Close (2921)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

It was reported the auto valve was not fully inflating/closing.The device was replaced with a new device.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.There wer no reports of the pt being harmed as a result.Should additional info become available a follow-up report will be submitted.

Manufacturer Narrative

Add'l information was received on july 01, 2015 confirming a return product was received.The device was decontaminated using 10% bleach solution.Product was released to supplier quality.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 was received on (b)(6) 2015.Third party manufacturer reviewed the historical work order for lot# 140600 which revealed that all testing met specifications.The returned unit was evaluated and did not function properly.The unit was examined under a microscope and showed that the valve assembly was correctly assembled but there was a rupture of the green silicone diaphragm.This caused the autovalve to not inflate properly.Third party manufacturer indicated that the green diaphragm rupture is usually caused by inconsistent pressure force performed while infusing fluid into the bladder.They were able to replicate the issue.No previous investigations are available.After a thorough review of the returned product and batch review no discrepancies or non-conformances were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.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.Sections have been updated to reflect the correct information.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on september 11, 2015.(b)(4).

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4861607
• MDR Text Key: 22252354
• Report Number: 1049092-2015-00360
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,foreign,other,user f
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2015

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 Expiration Date: 05/28/2019
• Device Model Number: ABV301
• Device Lot Number: 140600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/27/2015; 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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