MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) HALYARD MIC 20FR. JEJUNAL FEEDING DEVICE; TUBE, GASTRO-ENTEROSTOMY

Lot Number 20004138

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  Injury  

Event Description

To ir "(b)(6) 2021" for transgastric jejunostomy catheter check and exchange with return to ir (b)(6) 2021 for gastrostomy to gastrojejunostomy catheter conversion.On (b)(6) 2021, gj tube found to be partially dislodged likely from balloon rupture.Returned to ir for gastrostomy to transgastric jejunostomy catheter conversion (j tube was replaced).Fda safety report id# (b)(4).

• Brand Name: HALYARD MIC 20FR. JEJUNAL FEEDING DEVICE
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 12202797
• MDR Text Key: 263236063
• Report Number: MW5102654
• Device Sequence Number: 1
• Product Code: KGC
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20004138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR