MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOBBHOFF/NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION, 10FR; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

Went to place an dobhoff on a patient and found that the markings on the tubing were printed on the tubing backwards.Saved the tubing for nm and got another tube, double checking that the numbers were correct.Kendall dobhoff (b)(6).

Event Description

Additional information received on 12/05/2023 for report mw5148140 to correct the manufacturer's name and common device name.

• Brand Name: DOBBHOFF/NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION, 10FR
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 18141178
• MDR Text Key: 328434334
• Report Number: MW5148140
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/18/2023
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other