MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC; GOWN, SURGICAL

Model Number 9575

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Blood got through md's gown and onto his scrubs and lead that he was wearing for a tha.The gowns that we currently use are supposed to be impermeable, but this is happening quite frequently with his tha.

• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 7000 cardinal place; dublin OH 43017
• MDR Report Key: 8577228
• MDR Text Key: 143989199
• Report Number: 8577228
• 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 Model Number: 9575
• Device Catalogue Number: 9575
• 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