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	06/21/2024
Type of Reportable Event	Malfunction
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.It was reported that the tri-set leaking at bonded site.It was unknown if someone was directly operating the device at the time of event.It was unknown if there were other devices being used on the patient at the time of event that may have caused or contributed to the event.The event occurred during infusion with medication involve fentanyl.There was a delay in therapy due to tri sets needed changed out.
Additional Manufacturer Narrative
Received one (1) 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 #13993021.Customer provided two (2) pictures showing the set, no physical damage or anomalies were noted.Leak tested, all pass except leak noted on yellow bond between the check valve and the microclave.Confirmed customer complaint of "tri-set leaking at bonded site".Probable cause, not fully inserted during assembly.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: 19946386
• Report Number: 9617594-2024-01107
• Device Sequence Number: 8345851
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)290401(10)13993021
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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: 13993021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: FENTANYL., MFR UNK.
• Patient Age: 14 DA
• Patient Sex: Unknown