MAUDE Adverse Event Report: BARABAN MARC R MD BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	000283
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 huax0317 showed one other similar product complaints from this lot number.
Event or Problem Description
It was reported by the patient¿s mother that her child has a bard button that is leaking.The device was placed (b)(6) 2017, and has been leaking since the day after placement.The tab that closed the device came off and has never really had a good seal around the feeding tube.It appears the valve isn¿t closing.No patient injury was reported.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 2.4CM
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BARABAN MARC R MD; 823 sw mulvane st ste 200; topeka KS 66606
• MDR Report Key: 6835996
• Report Number: 3006260740-2017-01479
• Device Sequence Number: 655347
• Product Code: KGC
• UDI-Device Identifier: 10801741087865
• UDI-Public: (01)10801741087865
• Combination Product (Y/N): N
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 000283
• Device Catalogue Number: 000283
• Device Lot Number: HUAX0317
• 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: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1