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

Lot Number 30042537

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  Injury  

Event Description

Patient has a gastrojejunal feeding tube which is routinely changed, and currently has a malfunctioning balloon.Gj tube removed, balloon was deflated, and upon examination by the interventional radiologist, the balloon appeared to be leaking near the tube connector.A new tube was placed after testing the balloon, no leak identified.Placement confirmed by fluoroscopy.No patient harm.Supply chain manager to review any issues w/lot numbers.Fda safety report id# (b)(4).

• Brand Name: GASTROJEJUNEAL FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 10527782
• MDR Text Key: 206999194
• Report Number: MW5096574
• Device Sequence Number: 1
• Product Code: KNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

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 Lot Number: 30042537
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR