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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS BUTTON 18F TUBE, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
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.
 
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Brand NameBUTTON 18F
Type of DeviceTUBE, 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 Key6713565
MDR Text Key80262369
Report Number3006260740-2017-01032
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904779
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model Number000283
Device Catalogue Number000283
Device Lot NumberHUAX0317
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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