MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	AC136
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a 60" (152 cm) appx 2.2 ml, ext set, smallbore w/clave¿ clear, nanoclave¿ stopcock, 0.2 micron filter, spin luer where the reporter stated that that "rn noted the iv glucose tolerance test (gtt) tubing used to administer fentanyl to the patient to be increasing in volume on the syringe pump.The syringe pump alarmed "occlusion" at 1300, and this rn noted there to be clear drips coming off of the outside of the iv tubing near the stopcock on the glucose tolerance test (gtt) tubing.The medication was paused; new tubing was set up." there was patient involvement but no adverse event.
Additional Manufacturer Narrative
Investigation summary the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.No lot received for a device history record review.

• Brand Name: 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK
• 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: 23080030
• Report Number: 9617594-2025-01865
• Device Sequence Number: 15968737
• Product Code: FMG
• UDI-Device Identifier: 00887709125766
• UDI-Public: 00887709125766
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/17/2025

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: AC136
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FENTANYL, MFR UNKNOWN.; GTT TUBING, MFR UNKNOWN.
• Patient Sex: Unknown