MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING L; STOPCOCK, I.V. SET

Catalog Number	011-MC3302
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
A the event involved a 7" (18cm) appx 0.25 ml, smallbore ext set w/microclave® clear, clamp, rotating luer.It was stated in the emergency operating room of this hospital, where they had begun using this item, they were concerned about whether it truly came sterile in its packaging.When they pressed the package, the plastic compressed and, after a while, it swelled up again as if air was re-entering.They suspected there may be a hole that allowed air to enter and exit, which led them to doubt its sterility.This concern has been forwarded to the materials management department, which was the one who raised this question or incident.The same issue occurred with all the lots they have received, which is why they are questioning the sterility of item 011-mc3302.The status of the product at the time of event was upon removal of the primary package.The device was not reprocessed or re-sterilized.The event did not occur during patient use, and resulted in no delay or adverse event/harm.

• Brand Name: 7" (18CM) APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING L
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22349468
• Report Number: 9617594-2025-01372
• Device Sequence Number: 8527634
• Product Code: FMG
• UDI-Device Identifier: 00840619043223
• UDI-Public: 00840619043223
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: 011-MC3302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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