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

Model Number 9575

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 02/25/2019

Event Type  malfunction  

Event Description

When plastic wrap removed from sterile packaging, a part of the gown was exposed, rendering it unsterile.

• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8398411
• MDR Text Key: 138089959
• Report Number: 8398411
• 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: 03/05/2019

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: 9575
• Device Catalogue Number: 9575
• Device Lot Number: 18KBJ026
• 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: 03/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Type of Device Usage: N
• Patient Sequence Number: 1