MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number 19-3947A

Patient Problem Insufficient Information (4580)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

Sterile field ripped.

• Brand Name: CARDINAL HEALTH
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17661137
• MDR Text Key: 322398191
• Report Number: 17661137
• Device Sequence Number: 1
• Product Code: PEZ
• 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: 08/16/2023

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
• Device Operator: Other
• Device Model Number: 19-3947A
• Device Catalogue Number: 19-3947A
• Device Lot Number: 081244
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1