MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LOGICAL; CATHETER, UMBILICAL ARTERY

Model Number MX9644

Device Problem Backflow (1064)

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

Event Date 11/09/2019

Event Type  malfunction  

Event Description

Medex logical kids kit, 31inch closed blood sample kit with 30cc/hr flush device failure.Umbilical artery catheter (uac) on patient backing up with blood and would not stop.Changed out this part of the line with and the blood stopped backing up.It appears that the access port was damaged from the blunt access device.This uac tubing is less than 24hrs old.

• Brand Name: MEDEX LOGICAL
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9395258
• MDR Text Key: 168625994
• Report Number: 9395258
• Device Sequence Number: 1
• Product Code: FOS
• 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: 11/21/2019,11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX9644
• Device Catalogue Number: MX9644
• Device Lot Number: 3721152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Date Report to Manufacturer: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1