MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 120" 15 DROP PRIMARY SET W/3 MICROCLAVE® CLEAR, 3-PORT NANOCLAVE® MANIFOLD W/CHE; STOPCOCK, I.V. SET

Catalog Number	AM3025
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - additional phone number: (b)(6).The initial reporter indicated that the event occurred at least 10 times; however, no additional information was given pertaining to the additional instances.A search of the complaint database showed no prior report of these events.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 120" 15 drop primary set w/3 microclave® clear, 3-port nanoclave® manifold w/check valve, rotating luer, 1 ext that expereinced leakage and breakage during use.The report stated that the claves on the 3 prong break off very easily while in use causing a safety issue for their patients and the staff.This happened during patient use and propofol sprayed all over the crna, the floor and the patient.The patient was not harmed.They have the faulty piece left after the crna cleaned it off.The line was not salvaged because of the propofol in the line but the 3 prong was cleaned.This has happened at least 10 times.
Additional Manufacturer Narrative
Investigation summary: a photo was shared where 1 of the 3 nanoclaves is observed to be separated from the manifold, no additional physical damage or anomalies are observed.Complaint of separation can be confirmed based on the photo shared by customer.However, since no product sample was received for investigation a comprehensive failure investigation cannot be performed a probable cause cannot be determined.The device history record review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: 120" 15 DROP PRIMARY SET W/3 MICROCLAVE® CLEAR, 3-PORT NANOCLAVE® MANIFOLD W/CHE
• 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: 22819101
• Report Number: 9617594-2025-01693
• Device Sequence Number: 5766054
• Product Code: FMG
• UDI-Device Identifier: 00887709091757
• UDI-Public: 00887709091757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/15/2025

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: AM3025
• Device Lot Number: UNKNOWN
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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: PROPOFOL, MFR UNKNOWN.
• Patient Sex: Unknown