MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

Model Number	CHLOT01-08
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of endometrial cancer was admitted for a right chest port placement.When opening the cardinal health 200, llc octyl topical skin adhesive, dome tip, 0.8ml, the skin glue would not open.No glue would come out.No patient harm.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12149130
• Report Number: 12149130
• Device Sequence Number: 3774859
• Product Code: MPN
• UDI-Device Identifier: 10885380101588
• UDI-Public: (01)10885380101588(17)221128(10)P00221356
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/30/2021
• Report Date (Section F): 06/30/2021

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: CHLOT01-08
• Device Catalogue Number: CHLOT01-08
• Device Lot Number: P00221356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 06/30/2021