MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC; STOPCOCK, I.V. SET

Catalog Number	AC135
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a 120" (305 cm) appx 15.8 ml, 15 drop admin set w/3 clave¿ clear, nanoclave¿ stopcock, 2 check valves, spin luer, 2 ext where the reporter stated that the custom anesthesia set where the line primes fine and will administer fluid, suddenly stopped working 1-2 hours in.It was very problematic as they have to pause patient care and change out the line, causing a pause in fluid delivery (which if anesthesia drugs are currently being administered could cause a major issue).There was patient involvement reported but unknown patient harm.
Additional Manufacturer Narrative
Received two (2) used.List #ac135, 120" (305 cm) appx 15.8 ml, 15 drop admin set w/3 clave¿ clear, nanoclave¿ stopcock, 2 check valves, spin luer, 2 ext; lot #14082766.No visual damages or anomalies were observed.The reported complaint of no flow could not be confirmed.The returned samples were primed and leak-checked and met product specifications.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC
• 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: 21380887
• Report Number: 9617594-2025-00291
• Device Sequence Number: 8292649
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• UDI-Public: (01)00887709124417(17)290701(10)14082766
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: AC135
• Device Lot Number: 14082766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: UNSPECIFIED ANESTHESIA, MFR UNK.
• Patient Sex: Unknown