MAUDE Adverse Event Report: AVANOS MEDICAL, INC. NEOMED 5.OFR 40 CM PVC; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number FTS5.0V-EO

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

Feeding tube port that connects to tubing came dislodged from tubing.Fda safety report id # (b)(4).

• Brand Name: NEOMED 5.OFR 40 CM PVC
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 10967451
• MDR Text Key: 220704034
• Report Number: MW5098252
• Device Sequence Number: 1
• Product Code: KNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

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 Model Number: FTS5.0V-EO
• Device Catalogue Number: FTS5.0V-EO
• Device Lot Number: 20180505(?PKG NOT AVAIL)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• 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: 17 DA