MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3; STOPCOCK, I.V. SET

Catalog Number	AM3130
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 129" (328 cm) appx 24.3 ml 15 drop admin set w/3 clave¿ clear, 4-way stopcock, 3 check valves, 3-port nanoclave¿ manifold, spin luer, 2 ext where the customer reported that while in the process of delivering propofol through one of the ports on the device, manifold broke off while tightening the syringe on.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One device was received for evaluation.As received a nanoclave was observed to be broken off the manifold.The reported complaint of a broken manifold could be confirmed.The returned sample was observed to have a nanoclave disassembled from the manifold.The probable cause is from insufficient adhesive coverage during assembly in manufacturing.Lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3
• 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: 22650479
• Report Number: 9617594-2025-01553
• Device Sequence Number: 8769575
• Product Code: FMG
• UDI-Device Identifier: 00887709128224
• UDI-Public: (01)00887709128224(17)300501(10)14434529
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 09/03/2025

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: AM3130
• Device Lot Number: 14434529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROPOFOL, MFR UNK.
• Patient Sex: Unknown