• 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 CARDINAL HEALTH ORTHOPEDIC 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 CARDINAL HEALTH ORTHOPEDIC TRAY Back to Search Results
Model Number SOP12TJ38D
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem Insufficient Information (4580)
Event Date 04/28/2021
Event Type  Malfunction  
Event Description

A hair was found in the bottom of the sterile basin in a custom total joint pack. The sterile set up was discarded and a new pack was obtained.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDINAL HEALTH
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key11796668
MDR Text Key249685352
Report Number11796668
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/10/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberSOP12TJ38D
Device Catalogue NumberSOP12TJ38D
Device LOT Number571480
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2021
Event Location Hospital
Date Report TO Manufacturer05/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-