MAUDE Adverse Event Report: CARDINAL HEALTH, INC.; GOWN, SURGICAL

Lot Number 19CAX072 OR 19CAC072

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

The cardinal level four gown had blood strike through above both wrists.

• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 1 butterfield trail blvd; el paso TX 79906
• MDR Report Key: 8577229
• MDR Text Key: 143989171
• Report Number: 8577229
• Device Sequence Number: 1
• Product Code: FYA
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 19CAX072 OR 19CAC072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1