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	Fever (1858); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer called and stated that she has been using the alcoholic wipes that have been recalled and she has been in the hospital the last few months five times for infections.During a follow-up call on (b)(6) 2026, the customer reported being in and out of the hospital for the past five weeks.These issues began on (b)(6) 2026, with surgery to remove a liver tumor and the insertion of a biliary drain tube with a bag.Two weeks later, a blockage in the bag resulted in a second surgery for replacement.By late on (b)(6), she developed a 103 degree fever and her blood pressure dropped to 50/60.This led to a third surgery to change the bag due to an infection, with doctors suspecting sepsis.Although cultures and blood work were performed, she was unsure of the results at the time of the call but believed they were in her portal, noting that the hospital struggled to identify the source of her recurring infections.She has been on amoxicillin for two months.She stated that she is a seven-year cancer survivor and is now off chemotherapy.She also stated that she started using the alcohol prep pad box six weeks ago.She has been inserting the pads into her biliary tube before using a syringe to clear fluid.Additionally, she uses the wipes on a thermometer before placing it in her mouth.The nurse has also been using these wipes weekly to clean her skin, which has become raw and red.She mentioned being rushed from a medical urgent care to the hospital at one point due to these infections.She is receiving care at (b)(6) hospital.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A device history record review could not be conducted because a lot number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.There were no devices or photos returned for evaluation; therefore, the affected device could not be evaluated, and a definitive root cause could not be determined.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.

• 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: 24565953
• Report Number: 1423537-2026-00063
• Device Sequence Number: 9606183
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205(10)25J064662
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 25J064662
• 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: 03/08/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/17/2026; 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: Required Intervention; Hospitalization
• Patient Sex: Female