MAUDE Adverse Event Report: ICU MEDICAL, INC. MICROCLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number B3300

Device Problems Backflow (1064); Deformation Due to Compressive Stress (2889)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

Rn had just disconnected iv tubing from the patient's internal jugular (ij) catheter.The blood was backflowing out of the ij catheter through the microclave cap onto the bed.The cap appeared as if the inner part had stayed compressed after the line was disconnected.The cap was removed and observed that it had remained compressed as suspected.

• Brand Name: MICROCLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 8784595
• MDR Text Key: 150849751
• Report Number: 8784595
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B3300
• Device Catalogue Number: B3300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2019
• Date Report to Manufacturer: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA