MAUDE Adverse Event Report: ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9079

Device Problems Fluid/Blood Leak (1250); Increase in Pressure (1491); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Clear lumen of umbilical venous catheter (uvc) was beeping occluded steadily from when lines were hung after insertion.Blue lumen functioning properly.Multiple nurses and providers involved with troubleshooting.Line flushed and had good blood return.We pulled the uvc out <0.5cm, line remained patent with blood return.Repeat x-ray showed lines remained in good position.We removed the transducer, but it did not fix the problem.Finally we switched out the filter for a new one and the pressure on the alaris pump immediately went to zero.When the filter was unscrewed from the iv tubing, there was a little spray of fluid as though there had been pressure backing up.Defective filter placed in bag and left in office.Lot number unavailable, number provided below is from current stock on hand.Photos attached to file.No obvious defect in tubing on visual inspection, flushes normally now.Manufacturer contacted via product complaints email.Device will remain available in office pending request form manufacturer to have it returned.This event was categorized as minimal temporary harm.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11494871
• MDR Text Key: 240109619
• Report Number: 11494871
• 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