Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC STERILE TOWEL IN CARDINAL CARDIAC CUSTOM PACK; GENERAL SURGERY TRAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDINAL HEALTH 200, LLC STERILE TOWEL IN CARDINAL CARDIAC CUSTOM PACK; GENERAL SURGERY TRAY Back to Search Results
Catalog Number SAN12CCROT
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Thrombus (2101)
Event Date 08/27/2018
Event Type  Injury  
Event Description
Towel lint had been noticed from towels in the cardinal health custom packs and had been previously reported.Staff were notified to remove the towels from the custom pack before use.The pt was brought back today for a f/u post towel lint exposure.Today this pt presented with towel lint in the rc.The towels had been used on the sterile field to absorb excess.Lint was removed with suction from the pt's right coronary.Lint caused the vessel to thrombus.Stents were placed and a pronto thrombus catheter was used.Pt is stable but with having to place the add'l stents.The pt will require long term anticoagulation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STERILE TOWEL IN CARDINAL CARDIAC CUSTOM PACK
Type of Device
GENERAL SURGERY TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
MDR Report Key7889161
MDR Text Key120858015
Report NumberMW5079874
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSAN12CCROT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2018
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
-
-