MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 148" (376 CM) APPX 18.8 ML, 15 DROP PRIMARY SET W/2 CLAVE¿, REMV 3 GANG 4-WAY CL; STOPCOCK, I.V. SET

Catalog Number	SC158
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01may2026 has been used as a placeholder.The device is available for evaluation; however, has not been received.
Event or Problem Description
The event involved a 148" (376 cm) appx 18.8 ml, 15 drop primary set w/2 clave¿, remv 3 gang 4-way clave¿ stopcock, spin luer, 2 ext.It was reported that the middle stopcock had completely broken off.There was no reported patient involvement or harm.
Additional Manufacturer Narrative
One photo was shared by the customer, showing a broken nano clave connector from the stopcock, some plastic deformation and beach / stress marks were observed on the photo.The complaint of cracks was able to be confirmed based on the photo shared by the customer.However, without the return of the used sample a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The dhr lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 148" (376 CM) APPX 18.8 ML, 15 DROP PRIMARY SET W/2 CLAVE¿, REMV 3 GANG 4-WAY CL
• 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: 25552897
• Report Number: 9617594-2026-00636
• Device Sequence Number: 10731663
• Product Code: FMG
• UDI-Device Identifier: 00887709071551
• UDI-Public: (01)00887709071551(17)310401(10)14892284
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: SC158
• Device Lot Number: 14892284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2026
• 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