MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	REF8100-20
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
When putting enfit syringe into the end of tube to check residuals, the tube collapses down on itself.When used for drainage with enfit adaptors it won't drain.Fda safety report id# (b)(4).

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 14457322
• Report Number: MW5109803
• Device Sequence Number: 17439694
• Product Code: KNT
• UDI-Device Identifier: 00350770442945
• UDI-Public: (01)00350770442945
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: REF8100-20
• Device Catalogue Number: 8100-20
• Device Lot Number: 30153612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown