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

Model Number	2C6226
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an extension set separated during surgery.During the induction of anesthesia, a patient was receiving propofol and rocuronium when the extension set separated; further reported as "the tubing appeared to fall out of the male portion of the extension tubing".The surgical team was unable to administer medications through the extension set due to this malfunction; furthermore, due to the location of the separation, it was not possible to connect a new intravenous line to the extension set.It was also reported that the adapter was too tight to disengage from the angiocath that it was attached to.As a result, a new intravenous line was quickly established while the patient¿s airway was maintained via bag and mask.The surgery was completed without further issue.No further information was provided at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h4, h6 and h11.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: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21762132
• Report Number: 1416980-2025-01816
• Device Sequence Number: 8676375
• Product Code: FPA
• UDI-Device Identifier: 00085412003900
• UDI-Public: (01)00085412003900(10)R24G03055
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 2C6226
• Device Catalogue Number: 2C6226
• Device Lot Number: R24G03055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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: PROPOFOL; ROCURONIUM; UNSPECIFIED ANGIOCATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown