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

Model Number 50010

Device Problems Backflow (1064); Crack (1135)

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

Event Date 08/21/2020

Event Type  malfunction  

Event Description

Rn changed out iv tubing transducers due for routine change.After attaching the new sterile line and stop cock to the hub - blood flow was noted backing into the line.Line was immediately clamped and rn trouble shot with rsn (registered surgical nurse) and fellow.Crack was seen in the hub of the intracardiac line.Ct (cardiac thoracic) surgery called- line was left clamped and no longer in use.

• 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: 10739890
• MDR Text Key: 213195084
• Report Number: 10739890
• 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: 120 DA