MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD 20 FRENCH PEG TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Difficult to Remove (1528); Material Separation (1562)

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

Event Date 05/30/2023

Event Type  Injury  

Event Description

A 78 year old man with head and neck cancer and dysphagia required placement of peg feeding tube for nutrition.At the conclusion of use, the peg tube was removed in the outpatient setting.Upon pulling the tube for removal, the bumper was retained.Only the tube and outer connection were able to be retrieved.Plan is to have follow up phone intervention with patient to ensure he passes the bumper - otherwise further investigation and potentially invasive intervention will be necessary.

• Brand Name: BARD 20 FRENCH PEG TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17059066
• MDR Text Key: 316583949
• Report Number: MW5118131
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White