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

Model Number	6818
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rn opened approximately 18 covidien webcol alcohol preps where the pad was dry.Additionally, the pads to not smell as if they ever contained any isopropyl alcohol.

• Brand Name: WEBCOL
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8482000
• Report Number: 8482000
• Device Sequence Number: 1921719
• Product Code: LKB
• UDI-Device Identifier: 20884527020642
• UDI-Public: (01)20884527020642
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/21/2019
• Report Date (Section F): 03/21/2019

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: 04/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2019
• 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: 03/21/2019