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 Code	Disconnection (1171)
Health Effect - Clinical Codes	Shock (2072); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional contact information: (b)(6) canada (b)(6).D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a stopcock 4-way 5 gang with baseplate rotating luer and it was reported that the luer lock on manifold became completely disconnected from the needless connector on the patient's central venous catheter (cvc) on two occasions.There was patient involvement, and unknown patient harm.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
Additional information: there was no patient harm.
Event or Problem Description
The following additional information was received on (b)(6) 2026: the patient experienced brief periods where vasopressor support was interrupted causes some hemodynamic instability.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
Additional information can be found in b5 and d10 concomitant products.D9 - date returned to mfr: 3/6/2026 received one (1) used ac205 stopcock w/baseplate for inspection.No defects or anomalies noted.The set was leak tested from each access point.There was no leakage and each connection was secure with no propensity to disconnect.The male and female luer were measured and found to meet iso standards.The reported complaint could not be replicated or confirmed.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24361794
• Report Number: 9617594-2026-00148
• Device Sequence Number: 21382708
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: 00887709080010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: AC205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 04/10/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 02/27/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 CENTRAL VENOUS CATHETER, UNK MFR.; UNSPECIFIED CENTRAL VENOUS CATHETER, UNK MFR.; UNSPECIFIED VASOPRESSOR SUPPORT DRUG, MFR UNK.
• Patient Sex: Unknown