MAUDE Adverse Event Report: ICU MEDICAL TRIOX; CATHETER, OXIMETER, FIBEROPTIC

Model Number 50328-07

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 09/06/2016

Event Type  malfunction  

Event Description

The pa catheter became "kinked" during insertion of the catheter in the patient.The pa catheter could not be removed until the cordis was removed.

• Brand Name: TRIOX
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 6031140
• MDR Text Key: 57491664
• Report Number: 6031140
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016,09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 50328-07
• Device Lot Number: 3253340
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR