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

Model Number NC100

Device Problems Crack (1135); Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)

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

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Rn noticed crack in the end of the iv tubing.Iv tubing changed.Blue cap was pooling blood.Cap was changed and i noticed the device was pushed in and stuck.Following a blood draw neutron cap would not clear blood.Leading to an extra cap change and line access.This is a recurring issue.Icu medical contacted.There was no detectable harm.

• 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: 11912676
• MDR Text Key: 253510385
• Report Number: 11912676
• 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: 05/20/2021

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 Operator: No Information
• Device Model Number: NC100
• Device Lot Number: UNSURE, 5141624 CURRENTLY
• 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: 05/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4015 DA