MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CHEMOPLUS; POLYMER PATIENT EXAMINATION GLOVE

Model Number	CTS731M
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Chemotherapy gloves used to protect pharmacy staff from chemotherapy exposure are packaged with size large gloves in a package marked and sold as size medium.

• Brand Name: CHEMOPLUS
• Common Device Name: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8615308
• Report Number: 8615308
• Device Sequence Number: 1981696
• Product Code: LZA
• UDI-Device Identifier: 10884521132566
• UDI-Public: 10884521132566
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/14/2019
• Report Date (Section F): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CTS731M
• Device Catalogue Number: CTS731M
• Device Lot Number: 3A100718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2019
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2019
• 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: 05/14/2019