MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; UMBILICAL ARTERY TRANSDUCING TUBING

Model Number MX9644

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

"umbilical artery transducing tubing was dripping fluid out of the clamp with the orange dot.We tried to prime the tubing twice.".

• Brand Name: MEDEX
• Type of Device: UMBILICAL ARTERY TRANSDUCING TUBING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7620067
• MDR Text Key: 111735789
• Report Number: 7620067
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

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: No Information
• Device Model Number: MX9644
• Device Catalogue Number: MX9644
• Device Lot Number: 3515521
• Other Device ID Number: KIT 31
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1