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

Model Number A1141

Device Problems Contamination /Decontamination Problem (2895); Device Fell (4014); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2021

Event Type  malfunction  

Event Description

While priming the total parenteral nutrition (tpn), the port separated from the triset resulting in the tpn line to fall on the floor therefore making it no longer sterile.

• 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: 12452398
• MDR Text Key: 270875357
• Report Number: 12452398
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1141
• Device Catalogue Number: A1141
• Device Lot Number: 5018815
• 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: 09/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA