MAUDE Adverse Event Report: CARDINAL HEALTH ORAL GASTRIC TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A new ogt (orogastric tube) inserted, unable to verify patency via aspirate assessment and air aspiration.Upon further inspection, this rn noticed a defect in the tube (the lumen was fused together/occluded/manufacturer defect).Ogt was removed and new ogt inserted without harm to patient.What problem did the user have (check all that apply) :device failed (e.G.Broke, could not get it to work or stopped working); this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ORAL GASTRIC TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 17488326
• MDR Text Key: 320688672
• Report Number: MW5121024
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1