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

Model Number	2C6218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a three gang large bore stopcock manifold broke when turning a patient.During a norepinephrine and vasopressin infusion, the patient was turned, and the nurse noted the patient needed to have "increased vasopressin requirement".After the nurse investigated the lines, the manifold was observed to be broken.The patient became hypotensive with systolic blood pressure in the 80's; however, a new manifold was immediately placed on the central line, drips were reconnected, and the bp recovered within a minute.No further information was available at the time of this report.
Additional Manufacturer Narrative
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 when turning a patient.During a norepinephrine and vasopressin infusion, the patient was turned, and the nurse noted the patient needed to have "increased vasopressin requirement".After the nurse investigated the lines, the manifold was observed to be broken.The patient became hypotensive with systolic blood pressure in the 80's; however, a new manifold was immediately placed on the central line, drips were reconnected, and the bp recovered within a minute.No further information was available at the time of this report.
Additional Manufacturer Narrative
Correction: e3: occupation, g2: report source, g4: combination product, h1: type of reportable event, f10 clinical codes, and f10 impact codes.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was received for evaluation.A visual inspection was performed and observed that the stopcock was broken in two pieces.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h10 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: 20241258
• Report Number: 1416980-2024-05057
• Device Sequence Number: 8163142
• 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,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
• Device Lot Number: ASKU
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 10/22/2024; 11/07/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/25/2024; 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOREPINEPHRINE.; VASOPRESSIN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown