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

Model Number 8100-20

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2023

Event Type  malfunction  

Event Description

Avanos gastrostomy feeding tube with enfit connectors, end of gastric port cracked off.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS PEG TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17185564
• MDR Text Key: 317741773
• Report Number: MW5118695
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8100-20
• Device Catalogue Number: 8100-20
• Device Lot Number: 30248104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White