MAUDE Adverse Event Report: ICU MEDICAL, INC. NEUTRON CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number NC100

Device Problem Reflux within Device (1522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

When rn was drawing labs, neutron cap filled with blood.Labs were drawn with yellow stop cock, provided in labs kit.Rn promptly changed neutron cap.There was no detectable harm.The device was disposed of.Unsure of the device's lot number, might be lot # 5019395 or 5126619 (based on current stock on event date).

• Brand Name: NEUTRON CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11752144
• MDR Text Key: 248186947
• Report Number: 11752144
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NC100
• Device Lot Number: 5019395 OR 5126619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA