MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD BUTTON GASTROSTOMY TUBE, KIT, 18F FEEDING TUBE

Model Number 000283

Device Problems Fluid Leak (1250); Reflux within Device (1522); Defective Component (2292); Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiry date: 09/2022).

Event Description

It was reported that post feeding device placement, the device was allegedly difficult to open and the device leaked. It was further reported that the device was too thin and the patient experienced reflux and tissue damage. The procedure was completed using a device from another company. The current status of the patient is unknown.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 18F
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12876553
• MDR Text Key: 281270558
• Report Number: 3006260740-2021-05037
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 000283
• Device Catalogue Number: 000283
• Device Lot Number: HUDX1474
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/26/2021 Patient Sequence Number: 1