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 complaint of cracks on item ac205 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history record review couldn't be performed because the lot number for this complaint is unknown.
Event or Problem Description
The luer lock of 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer reportedly broke, resulting in abrupt discontinuation of life-sustaining medications.Patient arrived from the operating room and when the bed was pushed into the room it hit the manifold and the port which had the precedex infusing cracked off.Although there was patient involvement, there was no harm.
Additional Manufacturer Narrative
Corrected information can be found in section h6 component codes.

• 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: 23336130
• Report Number: 9617594-2025-02015
• Device Sequence Number: 9451954
• 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,Followup
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement 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: OTHER UNSPEC. LIFE SUSTAINING MEDICATION, MFR UNK.; PRECEDEX, MFR UNK.
• Patient Sex: Unknown