MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8538

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

The patient was observed during vital sign check to be bleeding from the picc line.Upon assessment, the end of the iv tubing was noted to be broken off and stuck in the clave on the picc line.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15923486
• MDR Text Key: 304899455
• Report Number: 15923486
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2R8538
• Device Catalogue Number: 2R8538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White