MAUDE Adverse Event Report: CARDINAL HEALTH, INC. WEBCOL; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	6818
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple complaints have been received regarding alcohol prep pads being dry upon opening.The following are the dates, units, and magnitude of the complaints.A progressive care nurse noted using 3 prep pads on a single patient before the fourth pad have enough moisture to complete the job.Lot numbers were not noted.An orthopedic nurse noted dryness in alcohol prep pads over the course of 2-3 weeks.Lot numbers, again, were not recorded.Pre-op/pacu nurse noted dryness in alcohol prep pads over the course of multiple weeks.Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter).The manufacturer was notified via purchasing department.Response is uncertain.Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter).The manufacturer was notified via purchasing department.Response is uncertain.Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter).The manufacturer was notified via purchasing department.Response is uncertain.

• Brand Name: WEBCOL
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 7000 cardinal place; dublin OH 43017
• MDR Report Key: 8593691
• Report Number: 8593691
• Device Sequence Number: 11273239
• Product Code: LKB
• UDI-Device Identifier: 20884527020642
• UDI-Public: (01)20884527020642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019
• Report Date (Section F): 04/11/2019

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: 6818
• Device Catalogue Number: 6818
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/11/2019