MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; ORTHOPEDIC TRAY

Device Problem Contamination (1120)

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

Event Date 08/23/2019

Event Type  malfunction  

Event Description

There was an insect found inside a sterile pack that came from the manufacturer.

• Brand Name: CARDINAL HEALTH
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9145952
• MDR Text Key: 160906311
• Report Number: 9145952
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

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: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1