MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD WIRE-GUIDED JEJUNAL FEEDING/GAST; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number ASDZF008

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2020

Event Type  Injury  

Event Description

J port added by placing the tube through the g tube.The tube became clogged and interventional radiology came bedside to declog.It appeared the j portion broke off.During bowel movement on (b)(6) 2020, patient appears to have passed the dobhoff tube.Fda safety report id #: (b)(4).

• Brand Name: BARD WIRE-GUIDED JEJUNAL FEEDING/GAST
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 10122976
• MDR Text Key: 194524715
• Report Number: MW5094852
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2022
• Device Lot Number: ASDZF008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization