MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON GASTROSTOMY TUBE, KIT, 24F; FEEDING DEVICE

Model Number	000285
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Seizures (2063)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However, two electronic videos were reviewed.The first video was evaluated and concluded.This is a movie of the injection of a gastrostomy tube.It is hard to tell how much is originating underneath the clear plastic stopper, but there appears to be a significant amount of fluid collecting on top of the plastic g tube stopper strap suggesting a ¿connection¿ problem with the injection tubing and not a leak from the g tube or from around the gastrostomy hole.The second video was reviewed and the video shows redness on the skin of the patient as well as the same leaking conditions that were observed in the first video minus the buildup of leaking fluid.The investigation is confirmed because of the leaking observed in the videos.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 08/2021).
Event or Problem Description
It was reported that some time post gastrostomy tube placement, the button valve allegedly leaked.It was further reported that the patient experienced burns in the gastro, major seizures, weight loss.The current patient status was unknown.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 24F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10384047
• Report Number: 3006260740-2020-02873
• Device Sequence Number: 13919663
• Product Code: KGC
• UDI-Device Identifier: 10801741087889
• UDI-Public: (01)10801741087889
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 000285
• Device Catalogue Number: 000285
• Device Lot Number: HUCU2440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other