MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE; STOPCOCK, I.V. SET

Catalog Number	A1003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 6" (15 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, nanoclave® t-connector, rotating luer was found to leak during patient use.It was stated in the report that the patient's white lumen was leaking as evidenced by wetness on the central venous line (cvl) vest as well as seen when flushing.The cap and tubing change was completed immediately, and the white lumen was capped although the luer lock was still not fully secure.White lumen was not used for the remainder of the shift and a computerized axial tomography( cat) team consult was placed to evaluate the issue in the morning.The cat team reviewed and indicated the issue was the t connector was swiveling and not connecting correctly to the lumen.The t connector did not have enough ridges to tighten onto the end of the lumen.Their team noticed the issue some time ago that the t connectors weren¿t fitting well.There was no patient harm reported.
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
No a1003 product samples, videos or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Lot history review was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE
• 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: 21528887
• Report Number: 9617594-2025-00403
• Device Sequence Number: 15567193
• Product Code: FMG
• UDI-Device Identifier: 00887709051034
• UDI-Public: (01)00887709051034(17)290901(10)14134618
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: A1003
• Device Lot Number: 14134618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Patient Sex: Unknown