MAUDE Adverse Event Report: CARDINAL HEALTH; CHLORAPREP STICK

Model Number 962795

Patient Problem Laceration(s) (1946)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

A glass-like substance came out of chloraprep stick while cleaning the patient's port site.The substance was on the floor and the armrest of the patient's chair.The patient obtained a cut on one of his fingers from the glass.

• Type of Device: CHLORAPREP STICK
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17821121
• MDR Text Key: 324301403
• Report Number: 17821121
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 962795
• Device Catalogue Number: 962795
• Device Lot Number: 2133683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2023
• Date Report to Manufacturer: 09/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1