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	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
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.The reporter stated that the line was changed at around 1700 and then they noticed an iv set triset was found tpn leaking in bed around 1800 by apn (advanced practice nurse).Then the rn (registered nurse) was feeding another baby and line was change with new triset at 1900.The original intended procedure was unknown.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, however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One photograph was provided by the customer; unable to determine cause of failure from the photograph provided.We also 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; for evaluation.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The yellow line of the trifuse set was observed to be leaking at the connection of the tubing and the microclave.The probable cause of the leak is from an incomplete insertion during assembly in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21040290
• Report Number: 9617594-2024-01891
• Device Sequence Number: 20946616
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/10/2025
• 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, MFR UNK.
• Patient Age: 2 MO
• Patient Sex: Male