MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,; STOPCOCK, I.V. SET

Catalog Number	MC330375
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a 6.5" (17 cm) appx 1.1 ml, smallbore quadfuse ext set w/4 microclave¿ clear (red, purple, tpn rings), 0.2 micron filter, 1.2 micron filter, 4 clamps, check valve, luer lock was found to be occluded during patient use.It was stated in the report that the product problem was lipids occluded.There was no patient harm reported.
Additional Manufacturer Narrative
Two (2) pictures were provided for evaluation.Unable to determine failure from the photo provided.No physical damage or other anomalies were observed.Received one (1) used.List #mc330375, 6.5" (17 cm) appx 1.1 ml, smallbore quadfuse ext set w/4 microclave¿ clear (red, purple, tpn rings), 0.2 micron filter, 1.2 micron filter, 4 clamps, check valve, luer lock.As received, the outlet filter vent of the filter was observed to be wetted out.The filter is loaded with total parental nutrition (tpn) lipid residuals.No additional damage or anomalies were observed.The secondary port clave was activated twice using an icu-provided syringe.No stick-downs were observed.The set was then leak-tested per specifications.Flow was established.There was leakage observed from the outlet filter.The complaint of lipids occluded can be confirmed on the inline filter.The probable cause of the clogged filter is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.Directions for use (dfu) states: a filter that clogs during infusion should be replaced.Sets with filter 0.2 micron should be changed at least every 72 hours.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,
• 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: 20207767
• Report Number: 9617594-2024-01290
• Device Sequence Number: 7769873
• Product Code: FMG
• UDI-Device Identifier: 00887709085671
• UDI-Public: 00887709085671
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: MC330375
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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: LIPIDS, UNK MFR.; TPN, UNK MFR.
• Patient Sex: Unknown