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 MICROCLAVE®, CLAMP, ROTATING; 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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, however, a device history review should be conducted.
Event or Problem Description
The event occurred on an unspecified date and involved a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer where the customer reported that after starting the iv, they attach the device to the hub and then they saw blood coming up the tubing.The customer stated that the first time it happened they thought they had mistakenly hit an artery.The customer also reported that it becomes an issue when they flush the line; fluid "squirts" out of the extension from the blue clamp end; it appears to be where the distal part of the tubing attaches to the clamp and they tried to change just the clamp piece, but it still occurred.There was patient involvement; harm was not reported as a consequence of the event.
Additional Manufacturer Narrative
Additional information h10.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed from the photo provided.Without the return of the sample, 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.

• Brand Name: 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, 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: 22687747
• Report Number: 9617594-2025-01583
• Device Sequence Number: 15820918
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)291101(10)14218132
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 10/03/2025

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: 14218132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 07/30/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/04/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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