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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CARDIOVASCULAR PROCEDURE KIT
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CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CARDIOVASCULAR PROCEDURE KIT Back to Search Results
Model Number SCV13VUCOL
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/06/2025
Type of Reportable Event Malfunction
Event or Problem Description
Operating room staff was preparing to perform a procedure, and as they took out the cardinal health "vascular u bar pack" and noticed there was a large hair under the tape and outer plastic packaging.A new sterile tray was retrieved and used without issue.Over the last two weeks, we have found four different trays with hair in them, one "total hip" pack, one "cysto pack", and one "minor u bar pack".All trays were unused, and it was caught before the tray was used on a patient.Manufacturer response for cardiovascular procedure kit, cardinal health (per site reporter).
 
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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 Key22210795
Report Number22210795
Device Sequence Number8262402
Product Code OEZ
UDI-Device Identifier10197106566756
UDI-Public(01)10197106566756
Combination Product (Y/N)N
Initial Reporter StateNH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/06/2025
Report Date (Section F) 06/09/2025
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 NumberSCV13VUCOL
Device Catalogue NumberSCV13VUCOL
Device Lot Number520966
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer06/16/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/16/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient Age55 YR
Patient SexFemale
Patient Weight75 KG
Date Report Sent to FDA06/09/2025
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