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 Codes	Separation Problem (4043); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it is unknown if it will be returned; a device history review will be performed.Additional related report numbers: 9617594-2025-01865-00; 9617594-2025-01810-00; 9617594-2025-01944-00; 9617594-2026-00116-00; 9617594-2026-00125-00.
Event or Problem Description
The event was reported via a user facility mandatory medwatch report number (b)(4).The date of the event was an unknown date in june 2025 and involved a 60" (152 cm) appx 2.2 ml, ext set, smallbore w/clave¿ clear, nanoclave¿ stopcock, 0.2 micron filter, spin luer where the customer reported that small air bubbles in tubing.It was reported that the nurse was priming neonatal intensive care unit (nicu) specific drip tubing for new morphine gtt; the nurse had connected tubing to port on umbilical venous catheter (uvc) with a blue clamp, and then noticed some small air bubbles still in tubing.The nurse went to disconnect from the uvc port to re-prime tubing and when attempting to disconnect, the top piece of the luer lock of the drip tubing snapped off, leaving the internal piece of the luer lock connected to the uvc.The nurse had difficulty attempting to unscrew the internal portion; the neonatal nurse practitioner (nnp) was successful at unscrewing.Morphine gtt was then primed using regular med tubing and filter as there had been ongoing reports of issues with the drip tubing.There was patient involvement (infant,) but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Complaint of leaks on item mc100 cannot be confirmed.Since 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 probable cause cannot be determined.The device history review (dhr) review couldn't be performed due to the lot number for this complaint was unknown.D9 - device available for evaluation: no.

• 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: 24349344
• Report Number: 9617594-2026-00147
• Device Sequence Number: 13291364
• Product Code: FMG
• UDI-Device Identifier: 00887709125766
• UDI-Public: (01)00887709125766(17)290801(10)14113540
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 14113540
• Was Device Available for Evaluation?: No
• 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: 04/23/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: MORPHINE.
• Patient Sex: Unknown