• 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 120ML STERILE SPECIMEN CONTAINER CONTAINER, SPECIMEN, STERILE

  • 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 120ML STERILE SPECIMEN CONTAINER CONTAINER, SPECIMEN, STERILE Back to Search Results
Model Number CHB13905
Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2017
Event Type  malfunction  
Event Description
Specimen cup that was in a sterile pouch has a piece of what looks like a piece of cardboard within the sterile package. The cup was not opened and another was used. Manufacturer response for sterile cup (per site reporter): rep will be able to pick up the specimen cup tomorrow.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name120ML STERILE SPECIMEN CONTAINER
Type of DeviceCONTAINER, SPECIMEN, STERILE
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
785 fort mill hwy.
fort mill SC 29707
MDR Report Key6957470
MDR Text Key89591185
Report Number6957470
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCHB13905
Device Lot Number1211684
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/11/2017
Event Location Hospital
Date Report to Manufacturer10/11/2017
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

-
-