MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266148
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported that they had a patient who had heart surgery.After chest tube insertion, the salem sump was inserted into each chest tube to suction the drainage.After sternal wiring, the scrub tech was having a problem pulling the salem sump from one of the chest tubes.The surgeon tried to pull it.The tip of the salem sump was noted missing when it came out.X-ray was done but radiologist was unable to visualize the tip.Xray result was relayed to surgeon.Incident report was made.Photo attached.Per additional information provided by the customer on 27feb2026, the salem sump was used to suction the drainage of the chest tube right after insertion of the chest tubes while the chest was still open and during sternal closure.The measurement on the tube serves as guide on how far the sump is inserted into the chest tube.Ideally the sump needs to be mobilized during sternal wiring.They state this is also a practice in some hospitals.Once the chest is closed, the sump is removed, then the chest tube is connected to the pleuravac.Unfortunately, after sternal wiring, the scrub person could not remove it, so the surgeon pulled it forcefully.The tip of the tube has not been located.The x-ray was read by the radiologist as ¿was not able to visualize the tip of the sump.¿ relayed to surgeon.The surgeon milked the chest tube while connected to the pleuravac.Obtained a fair amount of clots which are inside the pleuravac.The surgeon instructed the fellow to milk the chest tube even when the patient is in icu.Patient was transferred to another facility two days post op for continued care and is now walking around.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Additionally, no non-conformances were opened during the manufacturing process.The device was manufactured on september 24, 2024.A gemba inspection was performed to review the manufacturing process.All processes were reviewed and verified to be functioning correctly.No abnormal conditions were found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.It was not possible to identify a root cause related to the design, manufacturing process, or product quality.As part of continuous improvements, the dimensional inspection level has been increased from reduced to strict, operations and production personnel have received retraining, and monthly preventative maintenance has been performed.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: SALEM SUMP
• 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: 24501147
• Report Number: 1423537-2026-00052
• Device Sequence Number: 13290830
• Product Code: FEG
• UDI-Device Identifier: 10192253012842
• UDI-Public: (01)10192253012842(10)2425705764
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K880850
• 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
• Report Date (Section B): 04/06/2026

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: 8888266148
• Device Catalogue Number: 8888266148
• Device Lot Number: 2425705764
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown