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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred on an unspecified date in (b)(6) and involved a 60" (152 cm) appx 2.2 ml, ext set, smallbore w/clave¿ clear, nanoclave¿ stopcock, 0.2 micron filter, spin luer.The customer reported that at 3am, two nurses noticed that the gtt tubing that was infusing midazolam continuously was wet/leaking at the connection hub right next to the stopcock/proximal to the patient.The doctor was notified and s/he was able to manually tighten the connection a few centimeters away from stopcock to stop the medication from leaking.The gtt tubing had been primed and hung at 2000 and was not noted to be leaking during the priming process.The customer said that they cannot be sure when the tubing started to leak as the syringe volume was appropriately decreasing and the pump volumes correlated with the volume that was supposed to be delivered.There was patient involvement (infant) and no reported patient harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not been received.D4: only di provided as lot number is unknown.

• 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: 24308396
• Report Number: 9617594-2026-00116
• Device Sequence Number: 5314829
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: AC136
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MIDAZOLAM, MFR UNK
• Patient Sex: Unknown