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

Model Number ABV301

Device Problems No Device Output (1435); Defective Device (2588)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.One abviser was received attached to a saline bag for evaluation.The saline bag was discarded.The device was decontaminated with 10% bleach water and thoroughly dried.The device was forwarded to the third party supplier for evaluation.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.

Event Description

Complaint received from a dealer reporting that an auto-valve malfunction had occurred with the device.Reporter stated "on third day of usage, the auto-valve did not open.It resulted in the urine and saline could not be drained." reporter stated that the device was replaced.No patient information was provided.

Manufacturer Narrative

The batch record for abv301, lot# 141133 was reviewed by the manufacturer and showed that all functional testing met the specification and indicates no discrepancies related to the complaint issue.There was a deviation issued to the batch record, due to the replacing of saline with distilled water during post sterile functional testing.The deviation has no effect on the product complaint.The sub-assembly batch records used for building abv301 were reviewed by the manufacturer and no issue were found.A photograph and physical sample have been received for evaluation.The valve was opened and evaluated under the microscope and exhibited that the valve assembly had a missing micro filter component.The micro filter main purpose is to prevent any particulates from occluding the 0.0015" diameter laser drilled timing hole.The laser drilled timing hole was found occluded with foreign particulate inside.This issue will be monitored through the post market product 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 september 28, 2016.(b)(4).

• 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: 5847805
• MDR Text Key: 51188793
• Report Number: 1049092-2016-00361
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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: 141133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2014
• 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