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

Model Number MC100

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

Pt has port to r chest.I was preparing to stop her iv fluids and heparin lock her line prior to de-access and discharge.I noted that the line was connected to the port cap, but the connection looked crooked.I removed the line, and upon twisting the line off of the cap, the cap cracked, and top half of the cap fell off.The cap was then changed by two rns, the line was flushed and heparin locked.The cap was saved in a plastic bag and put in the mailbox for reference.Manufacturer response for microclave connector for iv tubing, microclave connector (per site reporter).The representative was called and told about the device by our procurement & strategic sourcing.However, i have no knowledge of any follow up.

• Brand Name: ICU MEDICAL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10447990
• MDR Text Key: 204195615
• Report Number: 10447990
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2020

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: Health Professional
• Device Model Number: MC100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA