MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE; STOPCOCK, I.V. SET

Catalog Number	MC330716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 102" (259 cm) appx 8.3 ml ext set bifuse pur standardbore/smallbore w/clave¿ clear, spiros¿ w/red cap, dual check valve, 1.2 micron filter, luer lock where the customer reported that during first 5 days of implementation, frequent failure (unspecified quantity) of the 1.2 micron in-line air filter on the medfusion sets was leaking parenteral nutrition.The leak was coming from the air vents occur within 24 hours of priming.The sample was connected to transfer set w/0.2 micron filter, clave.B33984.It is unknown if there was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
Two used devices were returned for evaluation along with one unspecified quadfuse.The devices were visually inspected.The filter was observed to be wetted out.The reported complaint of a leak could be confirmed.The probable root cause is from the temporary loss of hydrophobic properties during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 12/1/2025.

• Brand Name: 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE
• 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: 23625688
• Report Number: 9617594-2025-02207
• Device Sequence Number: 9031950
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: (01)00887709127364(17)300501(10)14425342
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MC330716
• Device Lot Number: 14425342
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/22/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: PARENTERAL NUTRITION, MFR UNK.; TRANSFER SET B33984, ICI MEDICAL, INC.
• Patient Sex: Unknown