MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 3.4CM; BUTTONS/WIZARD

Model Number	N/A
Health Effect - Clinical Code	No Code Available (3191)
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) of hubt1736 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient that she had a g-tube placed on friday, (b)(6) 2017 to replace her prior peg tube.She stated that when the port flips open to attach the tube, bile spills out.Medical services & support informed the patient that there is a valve that sometimes becomes stuck, allowing stomach contents to leak through.Ms&s gave the patient verbal instructions on how to use the decompression tube to decompress the stomach and also to replace the valve into the correct position.Patient was also advised to contact physician.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 3.4CM
• Common Device Name: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6959567
• Report Number: 3006260740-2017-01848
• Device Sequence Number: 16531440
• Product Code: KGC
• UDI-Device Identifier: 10801741087872
• UDI-Public: (01)10801741087872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 000284
• Device Lot Number: HUBT1736
• 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: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR