MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock where it was reported when flushing above the red port iv fluid was coming out of the red port.Peripherally inserted central catheter (picc) was patent and was stated to be a tri-set issue.There were no other devices being used on the patient at the time of the event that may have caused or contributed to the event.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
Corrected information can be found in e4 - initial report sent to fda and g2 - report source.
Event or Problem Description
Update: a medsun medwatch uf/importer report # (b)(4) was received on 06-aug-2025 and was obtained from ufmw: the report was completed by (b)(6) a risk manager from (b)(6) hospital.This was an initial type of report and event occurred in the hospital.Approximate age of device: 0 days.
Additional Manufacturer Narrative
Received one used list# a1141, 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock; lot# 14237904.No visual damages or anomalies were observed.The reported complaint of a leak could not be confirmed.The returned sample was tested and met product specifications.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10 concomitant products, h6 - adverse event problem component code.Additional information can be found in b5.Section e additional contacts: (b)(6).

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• Common Device Name: STOPCOCK, I.V. SET
• 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: 22372189
• Report Number: 9617594-2025-01403
• Device Sequence Number: 4388898
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)291201(10)14237904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 08/19/2025

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 Catalogue Number: A1141
• Device Lot Number: 14237904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 07/21/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/18/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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: B BRAUN IV TUBING.; PICC (PERIPHERALLY INSERTED CATHETER), MFR B BRAUN.; UNSPECIFIED IV FLUID, MFR UNK.; UNSPECIFIED IV FLUIDS, UNK MFR.
• Patient Age: 11 DA
• Patient Sex: Female