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 Codes	Irritability (2421); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event 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 at 0010 the nurse went to move the iv pole and noticed that it was wet.The customer then inspected tubing and noted that it was the morphine cont.Line that was leaking.When the new line was primed, they noticed that the new tubing was also leaking.They primed another set and that one was not leaking.There was patient involvement; the patient was irritable due to lack of morphine or being under hypothermic protocol.The customer reported 2 incidents.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
Received two used ac136 ext sets for inspection.No defects or anomalies noted.Each used set was leak tested per product specifications.There was leakage from the connection of the male luer of the stopcock to the female luer of the distal tubing on each set.Examination of the bond showed an incomplete insertion.The reported complaint can be confirmed.The probable cause is due to incomplete insertion during manual assembly of the manufacturing process.Corrected information can be found in d8 - was device serviced by third party? and in d10 and health effect - clinical code.

• 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: 22989352
• Report Number: 9617594-2025-01810
• Device Sequence Number: 21104826
• Product Code: FMG
• UDI-Device Identifier: 00887709125766
• UDI-Public: (01)00887709125766(17)290301(10)13924459
• 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): 10/09/2025

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: 13924459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/07/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: IV POLE, MFR UNK.; MORPHINE, MFR UNK.; MORPHINE, MFR UNK.
• Patient Sex: Unknown