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

Model Number 000285

Device Problem Fluid/Blood Leak (1250)

Patient Problem Seizures (2063)

Event Type  Injury  

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 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
• Type of Device: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791 ; RQ 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10384047
• MDR Text Key: 202171896
• Report Number: 3006260740-2020-02873
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087889
• UDI-Public: (01)10801741087889
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000285
• Device Catalogue Number: 000285
• Device Lot Number: HUCU2440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other