MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE® STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON; STOPCOCK, I.V. SET

Catalog Number	SC121
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
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 occurred on an unspecified date and involved a 60" smallbore trifuse ext set w/4-way clave¿ stopcock, 2 clave¿, 0.2 micron filter, rotating luer.It was reported that the filters leaked total parenteral nutrition (tpn) and required multiple changes.The event occurred while the product was in use with a patient but there was no human harm; the customer stated that the nurses stayed on top of this issue so their patients did not suffer an infection or hypoglycemia.This report is three of three.
Additional Manufacturer Narrative
One used sc121, 60" smallbore trifuse ext set w/4-way clave¿ stopcock, 2 clave¿, 0.2 micron filter, rotating luer was received for evaluation.It was noted that the inline filter vent of the used sc121 trifuse extension set was wetted out.Leakage was confirmed and the probable cause of the observed leakage is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interaction.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" SMALLBORE TRIFUSE EXT SET W/4-WAY CLAVE® STOPCOCK, 2 MICROCLAVE®, 0.2 MICRON
• 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: 17899372
• Report Number: 9617594-2023-00815
• Device Sequence Number: 11604701
• Product Code: FMG
• UDI-Device Identifier: 00887709040106
• UDI-Public: (01)00887709040106(17)271101(10)12733852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/13/2023

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: SC121
• Device Lot Number: 12733852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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, MFR UNK
• Patient Sex: Unknown