MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	MC330419
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
An incident involving 102" (259 cm) pur standardbore/smallbore transfer set w/microclave clear, dual check valve, 1.2 micron filter, luer lock.It was reported that the smof tubing was found to be leaking at the junction where the straight tubing is connected to the luer lock connection.Smof was noted to be leaking into linens and was not being delivered to patient.Upon removal of the tubing and manual administration using a syringe, the leakage could be reproduced.There was patient involvement and there was delay in therapy, but no harm reported.
Additional Manufacturer Narrative
Received one used device for evaluation; no defects or anomalies noted.The set was leak tested per product specifications.There was a channel leak from the bond pocket of the distal male luer to tubing.The tubing was dimensionally measured and found to have a smaller outer diameter, typical of when the tubing has been pulled by an external force and stretched the tubing.The bond was tested for bond integrity and found to meet functional specifications.A small piece of the tubing was missing and remained bonded to the bond pocket.The reported complaint of a leak can be confirmed.The probable cause is due to an external pulling force during use leading to a channel leak.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: 23529480
• Report Number: 9617594-2025-02154
• Device Sequence Number: 21374286
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: 00887709087552
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SMOF, UNK MFR.
• Patient Sex: Unknown