MAUDE Adverse Event Report: BARD ACCESS SYSTEM, INC. BARD J TUBE; TUBE, GASTRO-ENTEROSTOMY

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

Pt with gj tube for nutrition on x-ray discovered distal metal cap of j tube extension had disconnected requiring a return to operating room for removal and replacement of gj tube.Fda safety report id # (b)(4).

• Brand Name: BARD J TUBE
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC.
• MDR Report Key: 11372115
• MDR Text Key: 233531201
• Report Number: MW5099568
• Device Sequence Number: 1
• Product Code: KGC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR