MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; IV START KIT

Lot Number 620598

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

When 3cc syringe attached to iv extension tubing, no blood return.When extension tubing removed, blood return and labs able to be obtained.Iv was in place and flushing appropriately once extension tubing replaced with new kit.

• Brand Name: CARDINAL HEALTH
• Type of Device: IV START KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12165896
• MDR Text Key: 261471722
• Report Number: 12165896
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 620598
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2555 DA