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	Anemia (1706); Diarrhea (1811); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Loss of consciousness (2418); Epistaxis (4458); Skin Infection (4544); Decreased Appetite (4569); Swelling/ Edema (4577)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
According to the patient, she has a condition of being chronically ill.She was experiencing vomiting for several hours and diarrhea for several days.She was in and out of consciousness and couldn't hold food or water for several days.She checked her blood pressure and noticed it had dropped dangerously low (84/45, 90/48, and 60/42).Currently, she is on medication to stabilize her blood pressure.The patient also showed symptoms of throat swelling.She visited a hematologist and her blood work showed dangerously low levels of iron (6 g/l).The patient realized she uses cardinal health alcohol skin prep wipes (over 10 times a day) to regularly wipe her hands and the central line on her medical device.This is the procedure instructed to her by medical professionals.She at first believed she had food poisoning but then thought of calling cardinal health.Cardinal health confirmed a recent recall for the pads because of a discovery of two resistant strains of bacteria found on several batches.She further stated that she is still experiencing nausea, fatigue, nose bleeds, and a skin infection on her nose and lips.

• 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: 24612704
• Report Number: 1423537-2026-00072
• Device Sequence Number: 10181636
• Product Code: LKB
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female