MAUDE Adverse Event Report: Cardinal Health 200, LLC CARDINAL HEALTH; Cardiovascular procedure kit

Model Number	SCVDHCBCME
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
2 cardiac coronary bypass packs had brown pieces of debris in the blue bowls.Debris was taped and marked.Both packs share the same ref and lot.Manufacturer response for cardiovascular procedure kit, cardinal health (per site reporter).Unknown.

• Brand Name: CARDINAL HEALTH
• Common Device Name: Cardiovascular procedure kit
• Manufacturer (Section D): Cardinal Health 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 50802460
• Report Number: 50802460
• Device Sequence Number: 10544419
• Product Code: OEZ
• UDI-Device Identifier: 10198956285651
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2026
• Report Date (Section F): 08/28/2026

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: SCVDHCBCME
• Device Catalogue Number: SCVDHCBCME
• Device Lot Number: 699788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/28/2026