MAUDE Adverse Event Report: HIGH-FLOW 4-WAY 45 PSI STOPCOCK, OFF HANDLE POSITION, ROTATING ADAPTER; STOPCOCK, I.V. SET

Model Number DYNJSC401

Device Problem Flushing Problem (1252)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2021

Event Type  malfunction  

Event Description

This rn was drawing blood for labs through the neutron cap attached to the pt's central line.This rn attached a stopcock to the neutron cap became filled with blood and this rn could not flush the blood through the neutron cap.Then this rn changed the cap.There was no detectable harm in this event.The device has been disposed of.

• Brand Name: HIGH-FLOW 4-WAY 45 PSI STOPCOCK, OFF HANDLE POSITION, ROTATING ADAPTER
• Type of Device: STOPCOCK, I.V. SET
• MDR Report Key: 11640595
• MDR Text Key: 244712527
• Report Number: 11640595
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJSC401
• Device Catalogue Number: DYNJSC401
• Device Lot Number: 21BBS677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Date Report to Manufacturer: 04/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA