MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/CONTINU-FLO; STOPCOCK, I.V. SET

Model Number 2C6254S

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

The rn reports to the manager that 3 sets of the anesthesia tubing with the stop cocks had been noted to be loosening and had to be frequently retightened to prevent disconnection.Unable to sequester any of the items in question, but will be attaching pictures of the other packages of this item that are in stock on the unit.

• Brand Name: CLEARLINK/CONTINU-FLO
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. llinois route 120; round lake IL 60073
• MDR Report Key: 6724287
• MDR Text Key: 80420084
• Report Number: 6724287
• Device Sequence Number: 1
• Product Code: FMG
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2C6254S
• Device Lot Number: (10)DR17C02064
• Other Device ID Number: (01) 000854046303
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Type of Device Usage: N
• Patient Sequence Number: 1