MAUDE Adverse Event Report: Cardinal Health 200, LLC Cardinal Health; Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Model Number	8888266130E
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported it is very hard to pull the top off.The anti-reflux valve is frequently extremely tight.Even opening a new tube, the reflux valve is very tight straight out of the package.They're able to get it out, but have to pull on it pretty hard with both hands before it releases.This is not great for replacing the valve when the tube is in someone's nose.Even new out of the package it is still quite difficult to remove the anti-reflux valve.This is a little different from what it has been like for the last couple years.Twisting, pulling, wiggling.It is all difficult and takes a fair amount of force.The reporter states they are not the only person who has resorted to cutting the blue lumen in order to put a new valve in.Very frequently, it is difficult enough to remove the valve that they have been nervous about hurting the patient or dislodging the tube.
Additional Manufacturer Narrative
Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.

• Brand Name: Cardinal Health
• Common Device Name: Tube, Double Lumen For Intestinal Decompression And/Or Intubation
• Manufacturer (Section D): Cardinal Health 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): Cardinal Health; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; +1(508)618-3640
• MDR Report Key: 50774661
• Report Number: 1423537-2026-00286
• Device Sequence Number: 9424257
• Product Code: FEG
• UDI-Device Identifier: 10192253012835
• UDI-Public: (01)10192253012835(17)310131(11)260220(10)2605120864
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8888266130E
• Device Catalogue Number: 8888266130E
• Device Lot Number: 2605120864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown