MAUDE Adverse Event Report: ICU MEDICAL, INC. HIGH PRESSURE 3-WAY LUER LOCK STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 42353-01

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/21/2018

Event Type  malfunction  

Event Description

A high-pressure 3-way, luer lock stopcock was applied between the distal port of the central line and the vamp.The distal port of the central line had blood backed-up into it.The patient had a large puddle of blood behind him, soaked into the sheet on the chair.The central line was flushed and it was noticed that the stopcock was leaking.The connections were tight upon inspection.The stopcock was removed and discarded.There was no harm to the patient.

• Brand Name: HIGH PRESSURE 3-WAY LUER LOCK STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7960044
• MDR Text Key: 123555985
• Report Number: 7960044
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 42353-01
• Device Lot Number: 3620443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA