MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MS930
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.A device history lot review is pending.
Event or Problem Description
The event involved a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer where it was reported the device leaked from the connection piece three times.There was unknown patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The reported complaint of a leak 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, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10, section e (throughout) and h11.Additional contact (b)(6).

• Brand Name: 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, 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: 22062422
• Report Number: 9617594-2025-01076
• Device Sequence Number: 8478262
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)300101(10)14278808
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: MS930
• Device Lot Number: 14278808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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 FLUID/INFUSATE, MFR UNK
• Patient Sex: Unknown