MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number	2C6256
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified quantity of clearlink system continu-flo solution sets disconnected at the connection sites and had a tubing break.These issues occurred during a procedure and while in use in the hospital.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected with the naked eye and observed that the 4-way 3 gang stopcock/winged female ll/24" was separated.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17351695
• Report Number: 1416980-2023-03654
• Device Sequence Number: 17465388
• Product Code: FMG
• UDI-Device Identifier: 00085412073682
• UDI-Public: (01)00085412073682
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: Other
• Device Catalogue Number: 2C6256
• Device Lot Number: DR22L20031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown