MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC330523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.Additional reporter: (b)(6).
Event or Problem Description
The event involved a 127" (323 cm) appx 9.7 ml transfer set w/clave¿ clear, dual check valve, smallbore trifuse ext set w/1 pur yellow, 2 clave¿ clear (yellow, green rings), 2-0.2 micron filters, spin luer where it was reported that the trifuse extension set 0.2-micron filter was leaking at the green ring lumen.The event occurred during infusion of parenteral nutrition x 48 hours.Line was changed.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
Received one (1) used.List #mc330523, 127" (323 cm) appx 9.7 ml transfer set w/clave¿ clear, dual check valve, smallbore trifuse ext set w/1 pur yellow, 2 clave¿ clear (yellow, green rings), 2-0.2 micron filters, spin luer; lot #unknown.Sample provided shows no physical damage or other anomalies.Confirmed customer complaint of a leak found at the filter.The probable cause of the leak is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 19980649
• Report Number: 9617594-2024-01134
• Device Sequence Number: 20853769
• Product Code: FMG
• UDI-Device Identifier: 00887709092020
• UDI-Public: (01)00887709092020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• 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
• Report Date (Section B): 09/23/2024

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: MC330523
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/23/2024
• 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: TOTAL PARENTERAL NUTRITION, UNK MFR.
• Patient Sex: Unknown