MAUDE Adverse Event Report: HALYARD HEALTH, INC. MIC GJ TUBE; TUBE, GASTRO-ENTEROSTOMY

Catalog Number 0250-22

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

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

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Pt has gastrostomy-jejunostomy (gj) tube that is leaking at the connection site to the tube feeds.Have tried multiple adapters but have been unsuccessful in correcting the problem.Escalation continuing.Finally cardiovascular and interventional radiology (cvir) came to look at gj.Cleaned interior surface with q-tip and gj was then able to "lock" into place without leaking.Per cvir - if this does not continue to work may need to replace.These are supposed to "lock" into place with a little turn/twist of the gj adaptor but they do not always work.Presently not leaking.

• Brand Name: MIC GJ TUBE
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; 3rd floor west; alpharetta GA 30004
• MDR Report Key: 8585876
• MDR Text Key: 144265346
• Report Number: 8585876
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0250-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA