MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; STOPCOCK, I.V. SET

Model Number	2C6218
Medical Device Problem Codes	Backflow (1064); Fracture (1260)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date: the event occurred on an unspecified date in august 2024.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the stop cock joint of a three gang large bore stopcock manifold appeared cracked and subsequently the patient¿s blood pressure (bp) dropped.Thirty seconds after turning the patient, the nurses observed the patient¿s bp dropped (values not reported).The nurse immediately assessed all sites and noted a backflow of blood where the epinephrine was infusing.Upon following the line, the nurse saw the ¿medication bridge line was cracked in half (the 3-way bridge that is fused together not the 3 way stop cocks that are pieced together)¿.The nurse immediately relocated the infusion to another port.The emergency team was called to patient bedside and calcium chloride stick was administered.Patient blood pressure responded appropriately, and a ¿new bridge¿ was created for medication.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20832667
• Report Number: 1416980-2024-06953
• Device Sequence Number: 12921233
• Product Code: FMG
• UDI-Device Identifier: 00085412003863
• UDI-Public: (01)00085412003863(10)DR24E15048
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2C6218
• Device Catalogue Number: 2C6218
• Device Lot Number: DR24E15048
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPINEPHRINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown