MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION IV TUBING INTERLINK SYSTEM SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C6425
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Product 2c6425 baxter: i v tubing, at the y port site, the rubber part that the needle injects into will sometimes dislodge, which in turn will clog the entire iv line.In this case a pt was being put to sleep for anesthesia and iv access was compromised because of this issue, no drugs or fluids could get to pt until the line was completely changed for new tubing.Also, the same tubing brand (not sure of lot number) has caused this same problem about 3 or 4 other times.Another issue with the same tubing brand is that it is noticed that when trying to give medications thru the y port, the medications will actually back up into the bag, and not going down to the patient.It was not noted at the time that the yport rubber part had dislodged in these cases.Lot number of tubing in today's event is (10)r21f24069.Fda safety report id# (b)(4).

• Brand Name: IV TUBING INTERLINK SYSTEM SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13847930
• Report Number: MW5108398
• Device Sequence Number: 15015650
• Product Code: FPA
• UDI-Device Identifier: 00085412002149
• UDI-Public: (01)00085412002149
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2C6425
• Device Catalogue Number: 2C6425S
• Device Lot Number: (10)R21F24069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male