MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	Z2739
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2025 has been used as a placeholder.The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a 9" smallbore ext set w/clave, clamp, rotating luer where it was reported that seven smallbore extension sets malfunctioned while in use.Additionally, they were attached to arterial lines and when the plunger on the port was accessed for a blood draw it stayed engaged after the syringe was removed.There was patient involvement.
Additional Manufacturer Narrative
The initial mdr was submitted in error.The event was determined not to meet the manufacturer¿s reportability criteria because the device did not cause or contribute to a death or serious injury, nor did the malfunction present a risk that would be likely to cause or contribute to a death or serious injury if it were to recur.

• Brand Name: 9" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER
• 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: 23398983
• Report Number: 9617594-2025-02059
• Device Sequence Number: 21318546
• Product Code: FMG
• UDI-Device Identifier: 00887709027725
• UDI-Public: 00887709027725
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: Z2739
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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