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	10/31/2024
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 leakage at the bonded cap on the white lumen of the intravenous (iv) triset, which resulted in the need for the patient¿s total parenteral nutrition / lipids (tpn/il) to be discarded prematurely.Upon assessment, it was found that lipids were leaking from the bonded clave piece (white) of the triset.The event occurred during patient care in the c4c unit.It was noted that the device had not been reprocessed or reused.The patient involved was a 4-week-old female.There was patient involvement and unknown human harm.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: 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# 13878520 --> one used lits# unknown, 0.9% sodium chloride injection, usp bd 10ml syringe; lot# 4243592 no visual damages or anomalies were observed on the returned devices.The reported complaint of a leak could be confirmed.The line with the white clamp leaked during testing.The probable cause of the leak is from an incomplete insertion during the assembly process of manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in h2 health effect impact code.The customer did not outwardly allege any underdose to the patient.

• 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: 20883126
• Report Number: 9617594-2024-01750
• Device Sequence Number: 18320307
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)290101(10)13878520
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 13878520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: TOTAL PARENTERAL NUTRITION AND LIPIDS, UNK MFR.
• Patient Age: 28 DA
• Patient Sex: Female