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

Model Number	SBA12LPMFM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical pack was opened in sterile manner.Suction handle was found to be deformed and unusable.Item was removed from sterile field and replacement was provided.Supervisor and materials management notified.Pack information: basic set-up pack.Lot #: 401900.Exp.: [redacted date].

• Brand Name: CARDINAL HEALTH
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1320 don haskins; suite a; el paso TX 79936
• MDR Report Key: 21545881
• Report Number: 21545881
• Device Sequence Number: 12775146
• Product Code: LRO
• UDI-Device Identifier: 10197106786055
• UDI-Public: (01)10197106786055
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2025
• Report Date (Section F): 02/28/2025

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 Model Number: SBA12LPMFM
• Device Catalogue Number: SBA12LPMFM
• Device Lot Number: 401900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/28/2025