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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 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 generated a leak during patient use.It was stated in the report that triset on ij leaking from the teal lumen.There was no patient harm reported.
Additional Manufacturer Narrative
A couple of photos were shared by the customer, where set # a1141 is shown.However, no physical damage, leak, or anomalies are observed in the photos.One (1) used.List # a1141, 9.5" was returned for evaluation.As returned a leaking was observed from the base of the microclave near light green clamp.No additional damage or anomalies were observed.The set was tested as per procedure and the leak from the microclave and the check valve bond near the green clamp was confirmed.No other leaks along the device were observed.Complaint of leak can be confirmed.The probable cause was due to an incomplete insertion during the manufacturing process assembly at ensenada.A device history review (dhr) was performed and no relevant commodities, discrepancies, or nonconformances were identified that might have led to the condition reported by the customer.

• 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: 20464938
• Report Number: 9617594-2024-01458
• Device Sequence Number: 7880840
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: 09/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/16/2024
• 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: UNSPECIFIED FLUID, UNK MFR
• Patient Age: 2 MO
• Patient Sex: Male