MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.58 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 0.2 MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330532
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.Additional contact information (b)(6).
Event or Problem Description
An incident occurred involving a smallbore extension set with a microclave.The device was connected to a peripherally inserted central catheter (picc) line during a total parenteral nutrition (tpn) infusion.Initially, the pump triggered an alarm due to increased pressure, and medical staff attempted to troubleshoot the issue.When the alarm activated again, the tubing was examined more closely.During this inspection, the filter in the double pigtail was found to be wet and sticky, matching the properties of tpn solution.Further assessment confirmed that leakage had occurred.The faulty pigtail was subsequently replaced.The product had been newly connected at the end of the day shift, and the issue was identified within the first hour of the night shift.This type of incident had occurred previously.The event took place during active use, involved a patient, and resulted in no harm.

• Brand Name: 9" (23 CM) APPX 0.58 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 0.2 MIC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25389624
• Report Number: 9617594-2026-00528
• Device Sequence Number: 20134899
• Product Code: FPA
• UDI-Device Identifier: 00887709092457
• UDI-Public: (01)00887709092457(17)300901(10)14600285
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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 Catalogue Number: MC330532
• Device Lot Number: 14600285
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Sex: Unknown