MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AM6152
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 20" (51 cm) appx 1.9 ml, ext set, smallbore w/clave¿ clear, 2 6-port nanoclave¿ manifolds, 2 check valves, spin luer with item number am6152 and possible lot numbers 14602672, 14769303, 14805220: it was reported that the registered nurse and the patient's mother noticed that patient's sheets and blanket were wet, subsequently noticed that the manifold of the gtt line was leaking and not able to be screwed on tighter.The registered notified front line provider and cocktailed new drips in a septafuse instead of the manifold and replaced leaking manifold.This was third event where leaking was observed in the same spot within one week.As per the hospital's policy, they cannot return samples that have been used with a patient, so customer returned 3 unopened samples.This event occurred during infusion.There was patient involvement and no harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.

• Brand Name: 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25460687
• Report Number: 9617594-2026-00575
• Device Sequence Number: 21419542
• Product Code: FMG
• UDI-Device Identifier: 00887709122420
• UDI-Public: (01)00887709122420
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: AM6152
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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