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

Model Number	2C9216
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two (2) anesthesia sets had flow issues; further described as "inability to inject fluid through the tubing".This was observed when "priming" the sets with bupivacaine 0.5% using a 30ml non-baxter syringe.Switching to a 3cc unspecified syringe and applying pressure on the plunger allowed for the tubing to be primed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4 expiration date (update n/a), d9, h3, h4, h6 (replace codes), h11.H11: one (1) actual sample and a photograph was provided for evaluation.Visual inspection of the photograph identified the device primary packaging only.Visual inspection of the returned sample did not identify any abnormalities that could have contributed to the reported condition; all components were correctly place according to the specification.Pressure and blockage testing were performed and no leak was noted; however, a blockage was found at the junction of connector to tubing.Further inspection identified the female luer lock was blocked.The reported condition was verified.The cause of the blocked connector was related to manufacturing.A nonconformance has been opened to address this issue.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: NA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21647102
• Report Number: 1416980-2025-01292
• Device Sequence Number: 18081477
• Product Code: FPA
• UDI-Device Identifier: 00085412004235
• UDI-Public: (01)00085412004235(10)DR24J11048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: Other
• Device Model Number: 2C9216
• Device Catalogue Number: 2C9216
• Device Lot Number: DR24J11048
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: BD SYRINGE; BUPIVACAINE 0.5%
• Patient Sex: Unknown