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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 SCV13CEEMT
Device Problems Product Quality Problem (1506); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2023
Event Type  malfunction  
Event Description
From staff: it was reported by room staff that carotid endarterectomy packs have been having issues with the number of suture boots provided.The packs are arriving with 9 suture boots instead of the 10 required.Staff are concerned with a miss count as we are unable to determine if the missing suture boot is not somewhere lost within the pack.A new pack has been opened and the affected pack removed from room.No delay, no patient harm.This is the first time being reported however was told that this is an ongoing issue.Sales rep from cardinal health has been contacted in regard to this issue and is working on a solution.Manufacturer response for cardiovascular procedure kit, cardinal health (per site reporter).They are working on a solution.
 
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Brand Name
CARDINAL HEALTH
Type of Device
CARDIOVASCULAR PROCEDURE KIT
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key17341706
MDR Text Key319198865
Report Number17341706
Device Sequence Number1
Product Code OEZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberSCV13CEEMT
Device Catalogue NumberSCV13CEEMT
Device Lot Number064962
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2023
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer07/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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