MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC DLP; CATHETER, CANNULA AND TUBING

Model Number 50010

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/21/2020

Event Type  malfunction  

Event Description

Transthoracic rv line noted to be leaking around the hub upon assessment.Transthoracic rv line noted to be leaking around the hub upon assessment.Transducing line was changed [date redacted] @2350.Unsure if stopcock closest to the hub was changed during that time.Rv line clamped per md.Line clamped to prevent air from entering.There have been frequent cracks noted with the use of these transthoracic lines.We need to change the transthoracic lines we are currently using to something that is more durable.

• Brand Name: MEDTRONIC DLP
• Type of Device: CATHETER, CANNULA AND TUBING
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 10739893
• MDR Text Key: 213194982
• Report Number: 10739893
• Device Sequence Number: 1
• Product Code: DWF
• 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: 09/15/2020

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: 50010
• Device Catalogue Number: 50010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA