MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	011-MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer where the customer reported while the patient was being administered cisplatin, the drug began to leak from the rear luer connector on the extension tube connected to the catheter.The customer stated that the spill protocol was activated immediately.It was also reported that the silicone had shrunk, but no problems were detected when connecting it.Only after disconnecting the medication flowing through that tube did the serum flowing through the other tube begin to flow back through it.There was a delay in therapy, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
One used sample 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer was received for evaluation.Visual inspection and functional testing was carried out.Upon visual inspection no visual damages or anomalies were observed.Upon functional testing each seal was activated, and no stick downs were observed.The samples were tested & primed at gravity pressure with no issues.The samples were pressure leak tested at 25psi with no leaks observed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.The reported complaint of a leak could be confirmed from the photo provided; however, a leak could not be duplicated during testing.The probable cause of the leak is unknown.D9 - date returned to mfg.: 11/24/2025.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,
• 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: 23596099
• Report Number: 9617594-2025-02186
• Device Sequence Number: 15775519
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)300301(10)14363307
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 011-MC3316
• Device Lot Number: 14363307
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: CISPLATIN, MFR UNK
• Patient Sex: Unknown