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

Model Number MC9079

Device Problems Backflow (1064); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Air entrapped in the filter noticed when blood and lipids began backing up in tubing.Secondary umbilical venous catheter (uvc) total parenteral nutrition (tpn) line backing up blood close to infant.This port also had interleukin (il) infusing and med line that was clamped.Il also where noted as backing up as far as the filter yet infusion diluted with tpn.Filter was essentially dry on closer inspection.Packaging discarded, lot number provided below is from current stock on hand.Manufacturer notified of event via product complaint email - will store device in office pending return to manufacturer at their request.There was no harm detected.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11495186
• MDR Text Key: 240110239
• Report Number: 11495186
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MC9079
• Device Lot Number: 5136768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA