MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M; STOPCOCK, I.V. SET

Catalog Number	B33381
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a 118" (300 cm) appx 9.3 ml, transfer set w/anti-siphon valve, 3-way stopcock, 2 microclave®, 0.2 micron filter, luer lock where the customer reported that they have had leaks on the device at the location of the filters on and off the last few months.The status of the product at the time of event was during use on patient.The medication being used with this product is chemotherapeutic agent.The product was not reprocessed or re-sterilized prior to use and it was contaminated with biohazard or chemotherapeutic agent.There was patient involvement; there was delay in therapy.But no adverse event and no one was harmed as a result of the reported event.
Additional Manufacturer Narrative
One (1) used list# b33381, 118" (300 cm) appx 9.3 ml, transfer set w/anti-siphon valve, 3-way stopcock, 2 microclave®, 0.2 micron filter, luer lock; lot# unknown two (2) used list# b33381, 118" (300 cm) appx 9.3 ml, transfer set w/anti-siphon valve, 3-way stopcock, 2 microclave®, 0.2 micron filter, luer lock; lot# unknown --> two (2) used list# unknown, clave; lot# unknown.One (1) used list# b33381, 118" (300 cm) appx 9.3 ml, transfer set w/anti-siphon valve, 3-way stopcock, 2 microclave®, 0.2 micron filter, luer lock; lot# unknown --> one (1) used list# unknown, trifused extension set; lot# unknown --> two (2) used list# unknown, clave; lot# unknown no visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned samples were tested and observed to leak through the spike filter.The probable cause of the leak is from the temporary loss of hydrophobic properties of the filter vent material due to an infusate interaction.A device history lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M
• 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: 21708681
• Report Number: 9617594-2025-00570
• Device Sequence Number: 9952808
• Product Code: FMG
• UDI-Device Identifier: 00887709008069
• UDI-Public: 00887709008069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: B33381
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown