MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 24F; TUBE, GASTRO-ENTEROSTOMY

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 remains in the patient.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported to ms&s that the patient is experiencing the feeding tube adapter "popping out" and leaking.Ms&s advised the bard button continuous feeding tube adapter for the 24fr.Button is typically used for pump feeding.The bolus tube is for syringe feeding which might help if the pressure from the pump is too much.If the extension tube pops out, it is possible the device has been stretched out over time and may need to be replaced.It is also possible air / gas are pushing it out so using a decompression tube, may help.Ms&s also suggested decompressing the belly since the adapter "pops out" when the patient coughs.

• Brand Name: BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 24F
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7010406
• Report Number: 3006260740-2017-01981
• Device Sequence Number: 1345299
• Product Code: KGC
• UDI-Device Identifier: 00801741080845
• UDI-Public: (01)00801741080845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 000258
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1