MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC,) MIC-KEY GJ TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number MIC-KEY GASTRIC JEJUNAL FEEDING

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Went to interventional radiology on (b)(6) 2022 for conversion of gastrostomy tube to gastrojejunostomy tube; patient received low-profile g-j catheter (avanos mic-key gastric jejunal feeding tube.14 fr.X 22 cm.Lot 30190621.Exp: 2024-03-22).Balloon inflated with 5 ml sterile water.On (b)(6) 2022, the tube balloon was found ruptured and the tube dislodged.Returned to the interventional radiology suite later that same day for gastrojejunostomy catheter salvage and exchange.

• Brand Name: MIC-KEY GJ TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC,)
• MDR Report Key: 16043118
• MDR Text Key: 306247065
• Report Number: MW5113958
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: MIC-KEY GASTRIC JEJUNAL FEEDING
• Device Lot Number: 30190621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 9 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White