MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	AC205
Medical Device Problem Codes	Crack (1135); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a microclave breaking off could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a dhr review.
Event or Problem Description
The luer lock of a 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer reportedly broke, and discontinued the flow of unspecified life-sustaining medications.The patient was in transport from the ct scanner when a snap was heard and the norepinephrine line (the gtt was off) was disconnected.The microclave that was attached to the manifold was snapped in half, exposing a sharp edge and there was no way to reconnect the iv tubing.When en route back to unit, a second microclave connected to running nicardipine was snapped without significant pulling of the lines, in the same fashion.Blood was backing up in the line, and the patient's blood pressure was monitored until patient returned to their room and a new nicardipine gtt was hung.There was patient involvement but no harm.

• Brand Name: 5 GANG 4-WAY NANOCLAVE¿ STOPCOCK W/BASEPLATE, ROTATING LUER
• 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: 23336347
• Report Number: 9617594-2025-02016
• Device Sequence Number: 7807319
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: 00887709080010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: AC205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/20/2025
• 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: NICARDIPINE, MFR UNK.; NOREPINEPHRINE, MFR UNK.; OTHER UNSPEC. LIFE SUSTAINING MEDICATION, MFR UNK.
• Patient Sex: Unknown