MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B33971
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding 122" (310 cm) appx 3.5 ml, ext set, smallbore w/clave¿, luer lock where it was stated in the report that there was leaking at the connection site of bonded clave.Epinephrine drip was found to be leaking at a clear blue cap that is sealed by the manufacturer onto the long drip lines.There was no fluid accumulation on the syringe pump.Syringe was nearly empty, and the new epinephrine syringe was at bedside.New long drip line primed and immediately started double running.Patient required increase in epi drip, increase in calcium drip and a fluid bolus.There were patient involvement and no serious injury to the patient, but it required intervention.
Additional Manufacturer Narrative
Investigation summary: the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review could not be reviewed due to the unknown lot number.

• Brand Name: 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK
• 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: 24456179
• Report Number: 9617594-2026-00200
• Device Sequence Number: 13298947
• Product Code: FMG
• UDI-Device Identifier: 00887709122437
• UDI-Public: 00887709122437
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: B33971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/26/2026
• 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: CALCIUM DRIP, MFR UNKNOWN; EPINEPHRINE DRIP, MFR UNKNOWN; FLUID BOLUS, MFR UNKNOWN.
• Patient Sex: Unknown