MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC.; STOPCOCK, I.V. SET

Model Number	2C6218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a three gang large bore stopcock manifold broke.The patient had a right subclavian central line with one port.All medications including vasopressin, norepinephrine, and phenylephrine were all on one ¿long stopcock¿.The stopcock snapped and broke off.The patient¿s mean arterial pressure (map) dropped to the 50¿s.The nurse replaced the stopcock and the patient¿s blood pressure recovered without further incident.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11::the device was received for evaluation.During visual inspection the stopcock was observed broken.By the nature of the samples no additional testing could be performed.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to user error.The condition could happen due to the user¿s force, and it was determined that the reported condition cannot be generated by the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: 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 INTERNATIONAL INC.; 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: 20457913
• Report Number: 1416980-2024-05805
• Device Sequence Number: 7794230
• Product Code: FMG
• UDI-Device Identifier: 00085412003863
• UDI-Public: (01)00085412003863
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/07/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NOREPINEPHRINE.; PHENYLEPHRINE.; VASOPRESSIN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown