MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 110" 15 DROP PRIMARY SET W/2 CLAVE®, REMOVABLE 3 GANG 4-WAY STOPCOCKS, ROTATING; STOPCOCK, I.V. SET

Catalog Number	B9224
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred on an unknown date regarding a 110" 15 drop primary set w/2 clave®, removable 3 gang 4-way stopcocks, rotating luer, 2 ext where the reporter stated that "the tubing became disconnected after primary tubing was connected to patients iv." there was patient involvement, no patient injuries or adverse event and unknown delay in therapy reported.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 aug 2025 has been used as a placeholder.Investigation summary the reported complaint of tubing disconnecting 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.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The reported complaint of tubing disconnecting 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.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 110" 15 DROP PRIMARY SET W/2 CLAVE®, REMOVABLE 3 GANG 4-WAY STOPCOCKS, ROTATING
• 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: 23033689
• Report Number: 9617594-2025-01845
• Device Sequence Number: 15816420
• Product Code: FMG
• UDI-Device Identifier: 00887709013254
• UDI-Public: (01)00887709013254(17)290901(10)14143892
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: B9224
• Device Lot Number: 14143892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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
• Patient Sex: Unknown