MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 148" 15 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY CLAVE® STOPCOCK, ROTATING; STOPCOCK, I.V. SET

Catalog Number	SC158
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unspecified date involving a 148" 15 drop primary set w/2 clave®, remv 3 gang 4-way clave® stopcock, rotating luer, 2 ext where the customer reported that the anesthesia tubing sets were not flowing.They took the loop off at the end to see if it was that, and it didn't make a difference.They got a new set, and it flowed.There was patient involvement, no patient harm, and unknown delay in therapy.
Additional Manufacturer Narrative
Investigation summary: received twenty-five (25) new list# sc158, 148" 15 drop primary set w/2 clave¿, remv 3 gang 4-way clave¿ stopcock, spin luer, 2 ext; lot# 14310208.No visual damages or anomalies were observed.The reported complaint of no flow could not be confirmed from the samples provided.The returned samples were tested and met product specifications.Without the return of the used sample a probable cause cannot be determined.

• Brand Name: 148" 15 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY CLAVE® STOPCOCK, 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: 22332926
• Report Number: 9617594-2025-01349
• Device Sequence Number: 9104816
• Product Code: FMG
• UDI-Device Identifier: 00887709071551
• UDI-Public: (01)00887709071551(17)300201(10)14310208
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: SC158
• Device Lot Number: 14310208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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 ANESTHESIA, MFR UNK.
• Patient Sex: Unknown