MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	MC3316
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
The event involved a 7" (18cm) appx 0.37ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer where it was stated that the device had leaking from hub of y-site connected to patient while infusing chemotherapy.There was patient involvement, but no reported patient harm.
Additional Manufacturer Narrative
Additional information: drug information was provided in concomitant information.Investigation summary one (1) used list #011-mc3316, ext set, smallbore bifuse w/2 clave¿ clear was returned for evaluation.As received, no physical damage or anomalies were noted.No mating device was returned for evaluation.The sample was tested as procedure, after the test no leaks were noted.However, when the shuntless microclaves were dissembled a damage at the side and the top of one of the seal was noted, no additional damage or anomalies were noted.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Complaint of leaks can be confirmed.The probable cause of the tear observed at the side of the seal is due to incorrect use, based on dfu- do not use needles, blunt cannulas or luer caps on connectors.
Additional Manufacturer Narrative
The investigation was updated: one (1) used.List #011-mc3316, ext set, smallbore bifuse w/2 clave¿ clear was returned for evaluation.As received, no physical damage or anomalies were noted.No mating device was returned for evaluation.The sample was tested as procedure, after the test no leaks were noted.However, when the shuntless microclaves were dissembled a molding deformation at the side and top of one of the seals was noted, no additional damage or anomalies were noted.Complaint of leaks can be confirmed.The probable cause is due to an error during molding process at manufacturing plant.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18CM) APPX 0.37ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 2 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: 23317156
• Report Number: 9617594-2025-02006
• Device Sequence Number: 17385428
• Product Code: FMG
• UDI-Device Identifier: 00887709037458
• UDI-Public: (01)00887709037458(17)300401(10)14363362
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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: MC3316
• Device Lot Number: 14363362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 11/11/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/01/2025
• 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: ENFORTUMAB VEDOTIN, PADCEV.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown