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

Model Number ABV301

Device Problems Sticking (1597); Defective Component (2292)

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

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date: 05/2016.Based on the available information, this event is deemed to be a reportable malfunction.Based on the available information, no patient harm occurred.Follow up has been requested, but no additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Reporter stated "the auto-valve was stuck and did not work." reporter stated that the device had been in use for five (5) days when the issue occurred.Reporter provided no further details.

Manufacturer Narrative

(expiration date) 09/2016.The batch record review indicates no discrepancies.The batch records manufactured from december 1, 2012 through may 31, 2013 (including lot# 130428), showed all functional testing met the specifications.This issue will be monitored through the post market monitoring review process.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 june 09, 2016.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE
• 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: 5600751
• MDR Text Key: 43447402
• Report Number: 1049092-2016-00182
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

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: ABV301
• Device Lot Number: 130428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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