MAUDE Adverse Event Report: ICU MEDICAL SALES INC CENTRAL VENOUS CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 41401-23

Device Problem Disconnection (1171)

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

Event Date 09/09/2019

Event Type  malfunction  

Event Description

Upon assessing this pts right internal jugular (ij) triple lumen central line, the blue tube disconnected from the leur lock connector.The line was then discontinued from the patient, retained and sent to materials management.

• Brand Name: CENTRAL VENOUS CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL SALES INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9450938
• MDR Text Key: 170309654
• Report Number: 9450938
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 12/03/2019,11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 41401-23
• Device Catalogue Number: 41401-23
• Device Lot Number: 4067889
• 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: 12/03/2019
• Date Report to Manufacturer: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA