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

Model Number B2083

Device Problem Crack (1135)

Patient Problem Unspecified Infection (1930)

Event Date 07/20/2018

Event Type  malfunction  

Event Description

A patient in the nicu was receiving lipids for prematurity.It was noted that the filter cracked in the tubing on two separate occasions which poses an increased risk of clabsi (central line-associated bloodstream infection) in addition to the infant not receiving the appropriate nutrition.Manufacturer response: for small bore extension, small bore ext.Micron filter (per site reporter) no response yet.Given to field rep and complaint filed.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake cty UT 84123
• MDR Report Key: 7730845
• MDR Text Key: 115397557
• Report Number: 7730845
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3