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

Catalog Number 460802

Device Problem Defective Device (2588)

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

Event Date 10/12/2022

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.

• Brand Name: ORAL GASTRIC TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15804204
• MDR Text Key: 303711520
• Report Number: 15804204
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 460802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1