MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720205E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); High White Blood Cell Count (4594)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during patient admission, they underwent laparoscopic procedures including g [gastric] tube placement, diagnostic laparoscopy, and cholecystectomy.A ct scan revealed that the end of the g tube could not be identified.Subsequent attempts by the surgical team to deflate the balloon were unsuccessful, indicating a possible rupture.This complication likely led to the symptoms of increasing wbc, fevers, and positive blood cultures, suggestive of tube feeds potentially entering the abdomen.The compromised balloon necessitates a surgical replacement of the g tube.
Additional Manufacturer Narrative
Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.The device history record could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.A gemba on-site inspection of the manufacturing process was carried out.All processes were reviewed and their correct operation was verified.No abnormal conditions were found that could continue to trigger the reported condition.Due to the lack of evidence and the inability to analyze the sample, a root cause related to the product, manufacturing process, or design could not be identified.The appropriate internal personnel has been notified of the complaint for awareness purposes.In addition, a supplier corrective action request has been sent to the supplier to address the reported condition through a more robust investigation.¿ we will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 24709468
• Report Number: 1423537-2026-00087
• Device Sequence Number: 14955700
• Product Code: KNT
• UDI-Device Identifier: 10192253068801
• UDI-Public: (01)10192253068801
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205E
• Device Catalogue Number: 8884720205E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown