MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO - DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8404
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three (3) solution sets with duo-vent spike leaked chemotherapy from the tubing.The blue slide clamp key appeared to have sliced the tubing and caused a hole, and chemo began to leak at that point.This occurred when the blue slide clamp key was pulled out of the pump.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3: event date: occurred between approximately two weeks ago till 07aug2024.Should additional relevant information become available, a supplemental report will be submitted.
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 devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: one (1) actual device and a photograph of a sample were provided for evaluation.Visual inspection of the photograph and actual sample observed a cut in the tubing.Pressure and clear passage under water testing was performed on the actual sample and a leak was identified from the cut tubing.The slide clamp was visually inspected and no defects were observed that could generate the reported cut/leak.Pressure testing using the slide clamp was performed with no issues noted.The reported condition was verified.The cause of the cut tubing could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DUO - DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20140463
• Report Number: 1416980-2024-04749
• Device Sequence Number: 7398400
• Product Code: FPA
• UDI-Device Identifier: 00085412676630
• UDI-Public: (01)00085412676630(10)DR23I18055(17)250918
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

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 Expiration Date: 09/18/2025
• Device Model Number: 2R8404
• Device Catalogue Number: 2R8404
• Device Lot Number: DR23I18055
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 02/13/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/04/2024; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: PEMETREXED (ALIMTA).; UNSPECIFIED CHEMOTHERAPY.
• Patient Sex: Prefer Not To Disclose