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 Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported it is difficult to pull things out of the tube (the purple cap or the piece to connect to the suction tube).They've gotten stuck or broken.And per surgery, they suspect the air filter piece is not allowing effective suction.Per their (b)(4) sales representative, they went onsite to address the issue and opened up one of the customer's salem sumps and they physically could not remove the arv from the blue vent lumen.They tried twisting, pulling, and wiggling it to try to free it up.There was nothing they could do to get it removed.Per the sales representative, they also tried another salem sump from their own inventory and the same issue occurred.They've stated this is a major issue for healthcare workers who are trying to properly vent and prevent air when transporting patients.
Additional Manufacturer Narrative
Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported it is difficult to pull things out of the tube (the purple cap or the piece to connect to the suction tube).They've gotten stuck or broken.And per surgery, they suspect the air filter piece is not allowing effective suction.Per their cardinal health sales representative, they went onsite to address the issue and opened up one of the customer's salem sumps and they physically could not remove the arv from the blue vent lumen.They tried twisting, pulling, and wiggling it to try to free it up.There was nothing they could do to get it removed.Per the sales representative, they also tried another salem sump from their own inventory and the same issue occurred.This is a major issue for healthcare workers who are trying to properly vent and prevent air when transporting patients.Per additional information provided the issue is widespread at the moment.Every salem the customer pulls out of the package they find they are having an incredibly hard time getting the arv out, if at all.They actually broke one trying to get it out of the tube because they tried to use plyers.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not provided.Without a lot number, a specific review of production records, including verification of manufacturing parameters, in-process inspections, and final acceptance criteria for the specific lot associated with the reported problem, is not possible.As part of the investigation, a gemba (on-site inspection) of the manufacturing process was carried out.It was determined that the current process and controls were being followed correctly, including sub-assemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could continue to trigger the reported condition.As a result, it was concluded that the current manufacturing activities are running according to product specifications, meeting quality acceptance criteria, validation process and release procedures.A device was not received for investigation.Only a video was provided, which is insufficient to confirm the reported condition or determine the root cause.A corrective and preventative action has been initiated to address the reported condition.We will continue to monitor the process, customer complaints, and feedback notifications to detect any adverse trends that require immediate attention.

• 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 ; 5086183640
• MDR Report Key: 24203287
• Report Number: 1423537-2026-00021
• Device Sequence Number: 17532227
• Product Code: FEG
• UDI-Device Identifier: 10192253012835
• UDI-Public: (01)10192253012835
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2026

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
• Device Model Number: 8888266130E
• Device Catalogue Number: 8888266130E
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/28/2026; 01/30/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown