MAUDE Adverse Event Report: TELFLEX MEDICAL TRIPLE LUMEN CATHETER; TRIPLE LUMEN NON-COATED

Device Problems Knotted (1340); Split (2537)

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

Event Date 12/31/2013

Event Type  Injury  

Event Description

During right subclavian catheter placement, the guide wire was attempted to be removed.The guide wire split in two and also tied in a knot.It was unable to be removed until ct surgery was called to remove it.No apparent ill effects to the patient.

• Brand Name: TRIPLE LUMEN CATHETER
• Type of Device: TRIPLE LUMEN NON-COATED
• Manufacturer (Section D): TELFLEX MEDICAL; reading PA
• MDR Report Key: 3580814
• MDR Text Key: 4036674
• Report Number: MW5033874
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR