MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC WEBCOL; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	5110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that unfortunately, they have been using this product on an individual who has cancer, is receiving chemo and immunocompromised and was recently hospitalized for infection.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A non-conformance record review for the reported lot number was conducted.All in-process and final acceptance inspections were performed in accordance with established procedures.Inspection results were within acceptable limits, and no manufacturing or inspection anomalies related to the reported issue were identified.Samples were provided for evaluation, but the reported issue could not be observed at this time.However, a corrective and preventive action has been initiated to further investigate the reported issue.We will continue to monitor and take additional actions, as applicable.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.Section b3 has been updated to include the event date.Section d4 has been updated to include the lot number and udi-pi information.Section e1: initial reporter address has been updated.Section h6: clinical code and impact code updated.
Event or Problem Description
The customer reported that unfortunately, they have been using this product on an individual who has cancer, is receiving chemo and immunocompromised and was recently hospitalized for infection.Additional information provided by the customer and stated that the patient began using webcol wipes on march 7, 2026.On march 16, 2026, the patient developed symptoms of neutropenic fever and was hospitalized due to an enterococcus faecalis infection.During hospitalization, the patient received ampicillin.The patient's current chemotherapy regimen includes carboplatin and etoposide, and the patient is currently immunocompromised.Other medications the patient is currently taking are: skyrizi, doxazosin mesylate, famotidine, carvedilol, low-dose aspirin, acyclovir, amlodipine desylate.The patient has known allergies to ibuprofen and iodinated contrast media.

• Brand Name: WEBCOL
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24780576
• Report Number: 1423537-2026-00093
• Device Sequence Number: 14985686
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205(10)25K080162
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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?: No
• Device Model Number: 5110
• Device Catalogue Number: 5110
• Device Lot Number: 25K080162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/21/2026
• 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: Hospitalization
• Patient Sex: Unknown