MAUDE Adverse Event Report: ICU MEDICAL, INC. 7.5IN (19CM) APPX 1.7ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR; STOPCOCK, I.V. SET

Model Number MC33722

Device Problems Break (1069); Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2022

Event Type  malfunction  

Event Description

Iv tubing was disconnected from the patient and had broken at the junction where the three lines on the trifuse meet.Iv fluids (tpn/intralipids) were on and running but were going into the bed instead of the patient.

• Brand Name: 7.5IN (19CM) APPX 1.7ML, TRIFUSE EXT SET W/3 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: 15102502
• MDR Text Key: 296572858
• Report Number: 15102502
• 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: 07/25/2022

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 Model Number: MC33722
• Device Catalogue Number: MC33722
• Device Lot Number: 5924253
• 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: 07/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA
• Patient Sex: Male