MAUDE Adverse Event Report: HALYARD / AVANOS MEDICAL, INC. HALYARD FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number REF 8100-18

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Vet has a peg tube, which is the only way he can receive nutrition or medications.The portion of connection to a feed pump, or to connect a syringe to give meds is cracked and leaking, therefore needing replacement.Fda safety report id# (b)(4).

• Brand Name: HALYARD FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): HALYARD / AVANOS MEDICAL, INC. ; GA
• MDR Report Key: 8544964
• MDR Text Key: 143079227
• Report Number: MW5086091
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF 8100-18
• Device Lot Number: AA8134D18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Age: 72 YR