MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8519

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2021

Event Type  malfunction  

Event Description

When priming a new iv tubing set, the bottom y site detached from the rest of the tubing.No significant force was used.Sedation was being primed and the patient could have been harmed if the loose connection had become disconnected without the rn noticing.Clearlink system continu-flo solution set 112" (2.8m) @ luer activated valves lot r21d06129, 00085412048994.

• Brand Name: CLEARLINK/CONTINU-FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12473834
• MDR Text Key: 271458033
• Report Number: 12473834
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8519
• Device Catalogue Number: 2C8519
• Device Lot Number: R21D06129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other