MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP CLEARLINK DUO FLO; IV TUBING, SECONDARY

Catalog Number 2C8607

Device Problem Detachment Of Device Component (1104)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

Iv line was checked prior to transport to l&d, line was flowing properly without complication.Upon arrival to l&d, iv tubing had detached at stopcock and patient was bleeding from the detached iv tubing.During transport of pt, iv tubing became disconnected at stopcock and pt was noted to be bleeding from this site.No treatment was necessary.

• Brand Name: CLEARLINK DUO FLO
• Type of Device: IV TUBING, SECONDARY
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; 25212 w. illinois route 120; rlt-10; round lake, IL 60073
• MDR Report Key: 5450423
• MDR Text Key: 38642884
• Report Number: 5450423
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 2C8607
• Device Lot Number: DR15E191010
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2016
• 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
• Patient Age: 22 YR