MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON 18F; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 000283

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Emotional Changes (1831)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of huax0317 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported by the patient's mother that the feeding button continues to leak when the cap is closed.The mother stated that when the cap is open it will drain like an "open" facet.When its "closed" it drips like a leaking facet.This has caused stomach acid to leak on her son's skin and caused him to be agitated.She would like to know if there was a change in the design of the button.In the past her son could go months before the device needed to be replaced, now she has replaced two in the last four months.The mother noted that in the past there has not been a company logo on the device.She has noticed with the two recent replacement devices the company logo is imprinted on the button.She would like to know if a change was made to the device that is causing the button to leak when the logo was added to the device.She has requested a ifu be sent to her for assistance in replacing the patient's device.This file addresses the initial button replacement.

• Brand Name: BUTTON 18F
• Type of Device: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6713565
• MDR Text Key: 80262369
• Report Number: 3006260740-2017-01032
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087865
• UDI-Public: (01)10801741087865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 000283
• Device Catalogue Number: 000283
• Device Lot Number: HUAX0317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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
• Patient Age: 26 YR