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

Model Number SOP13OSEMT

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2024

Event Type  malfunction  

Event Description

From staff: rn circulator 1 and relief cst (certified surgical technologist) were setting up for case.All instruments and supplies were opened as usual.As relief cst was sorting through items, a hair was noticed on a marker that had come from the sterile procedure pack, therefore contaminating the entire back table and all supplies.Spd was called immediately to re-pick the case.Fill-in team leader was notified and advised that we place the item with the hair in a biohazard bag along with the information sheet from the sterile pack.

• 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: 19190775
• MDR Text Key: 341132624
• Report Number: 19190775
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SOP13OSEMT
• Device Lot Number: 221887
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 70 KG