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

Model Number SOP12ARKGT

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Cardinal health arthroscopy pack had 9 raytecs instead of 10 as listed.

• Brand Name: CARDINAL HEALTH
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 10307282
• MDR Text Key: 199851505
• Report Number: 10307282
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SOP12ARKGT
• Device Catalogue Number: SOP12ARKGT
• Device Lot Number: 565955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1