MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE CLEAR; STOPCOCK, I.V. SET

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

Patient was in the hyperbaric chamber and when he came back to the unit his central lien lumen would not flush on all three ports.The vacucontainer was removed, flushed and the central line without it and the central lien worked.After each hyperbaric chamber "dive" his vacucontainers that did not have fluids running through, the spring loaded middle portion was locked down inside the vacucontainer.This required replacements after each dive.

• Brand Name: MICROCLAVE CLEAR
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8472776
• MDR Text Key: 140601724
• Report Number: 8472776
• 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: 02/18/2019,02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7665 DA