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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Recieved one 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; lot #13551095.Lipid solution residuals observed in used list #mc330375 and mating device of one used.List #unknown, 0.9% sodium chloride 10ml syringe; lot #3142761.The used mc330375 extension set returned had visible lipids within the fluid path and within the inline filters.No other anomalies or damage were observed.The mc330375 extension set was primed and pressure leak tested.Bag 2 filter line a: primed without difficulty.No leakage at any location along the line.Bag 2 filter line b (tpn): primed without difficulty.No leakage at any location along the line.There was leakage observed at the hard to hard bond between the male luer of the trifuse adapter and the female luer of the check valve.Channel leak.The probable cause of the leak is typical of insufficient solvent coverage during manual assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved 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 where it was reported through investigation, that one sample was confirmed to have a bonding channel leak.The probable cause of the leak is typical of insufficient solvent coverage during manual assembly.According to the original complaint provided by the customer the event was not detected prior to direct patient use.There was no blood loss, no unprotected chemo exposure, and no medical/surgical intervention required.There was patient involvement, no adverse operator consequences and no delay in critical therapy reported.

• 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: 17870293
• Report Number: 9617594-2023-00794
• Device Sequence Number: 18042680
• Product Code: FMG
• UDI-Device Identifier: 00887709085671
• UDI-Public: (01)00887709085671(17)280301(10)13551095
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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: 13551095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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.
• Patient Sex: Unknown